JP2023043888A - Medical devices comprising detachable balloons - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide medical devices comprising detachable balloon catheters or catheter assemblies.

SOLUTION: The present disclosure relates to medical devices comprising detachable balloons and catheter assemblies, where the detachable balloons are polymer balloons, metal balloons, polymer-coated metal balloons, and metalized polymer balloons. Various means of attachment and detachment of the balloons to the catheter assemblies are described. Kits and uses of systems having one or more medical devices, detachable balloons, and elongated or expandable bodies are also disclosed.

SELECTED DRAWING: Figure 23

COPYRIGHT: (C)2023,JPO&INPIT

Description

(Cross reference to related application)
This disclosure relates to U.S. Provisional Patent Application No. 62/476,533, filed March 24, 2017, entitled "Expandable Body Device and Method of Manufacture and Use"; U.S. Provisional Patent Application No. 62/553,705, filed September 1, 2017, entitled "Metalized, Partially Metalized, Encased, Expandable Body Apparatus and Method of Manufacture and Use"; January 2018, entitled "Metal, Polymer, Metallized, Metal-Plated, Partially Metallized, Partially Metal-Plated, and Metal-Encased Expandable Body Medical Devices and Methods of Manufacture and Use." U.S. Provisional Patent Application No. 62/623,287, filed May 29; No. 62/629,532, filed Feb. 12, 2018, entitled "Wrap Medical Devices and Methods of Manufacture and Use," the entire contents of each of which are incorporated by reference in their entirety. incorporated herein.

The present disclosure relates to a first medical device comprising a balloon and a catheter or catheter assembly that is pleated, folded, expanded, and separated from the catheter or catheter assembly while the catheter or catheter assembly is removed from a human patient. The balloon "detachable balloon catheter" can be delivered to a desired location in a patient in such a way that the expanded balloon can be retained within the patient's body. The present disclosure also describes a second medical device comprising an elongated or expandable body configured for use with a removable balloon catheter, using all or a portion of the elongated or expandable body. to help maintain the size, shape, or position of the detached balloon of the removable balloon catheter. Systems and kits comprising a removable balloon catheter medical device and one or more elongated or expandable body medical devices are described. comprising a detachable balloon catheter medical device and one or more elongated or expandable body medical devices for use in saccular aneurysms, arteries, veins, left atrial appendages, paravalvular leaks, other blood-containing structures, biological The use of a detachable balloon catheter medical device or system for reducing the flow of blood or other biological fluids in conduits and biological spaces is described. Also disclosed are kits comprising a removable balloon catheter medical device and one or more elongated or expandable body medical devices, optionally with other medical devices.

The ability of percutaneous medical devices to reach specific locations within the body depends on several factors. First, the device has enough energy to reach from where it is inserted (i.e., the insertion site) to where treatment is desired (i.e., the treatment site). length. Second, the device should be flexible enough to navigate a tortuous path from the insertion site to the treatment site, a property known as "traceability." For embolic devices, trackability includes the flexibility of the catheter or catheter assembly used to place the implant as well as the implant itself. However, increasing the flexibility of the implant to improve the ability of the medical device to reach a particular location within the body increases the risk of it later collapsing or compressing, resulting in the treated blood-containing area. It may potentially lead to re-opening of structures, biological conduit segments, or biological spaces. Third, the device should have a sufficiently low outer diameter or "profile" to easily pass through arteries, veins, or other biological conduits or spaces with small or irregular lumen diameters. Fourth, devices can generally be placed more easily and accurately when delivered via a guidewire. However, adding a guidewire lumen to the medical device typically increases the outer diameter and may offset some of the advantages of the "over-the-wire" approach.

An aneurysm is a localized excessive enlargement of an artery caused by weakening of the arterial wall. Aneurysms can rupture without warning and cause internal bleeding. Bleeding from a ruptured aneurysm in the brain causes stroke and sometimes death. In the extracerebral body, bleeding from a ruptured aneurysm can cause hypotension and sometimes death. There are two main types of aneurysms, fusiform aneurysms and saccular aneurysms. A round or saccular aneurysm connected or attached to an artery or arterial bifurcation by a saccular aneurysm neck (or neck or neck). Saccular aneurysms can occur throughout the body, but are most commonly found in the arteries of the brain. A fusiform aneurysm is an aneurysm's outer bladder that extends in all directions without a definite neck or stem. Fusiform aneurysms are less common than saccular aneurysms, and because they rarely rupture, they are often left untreated. Because the rate of spontaneous rupture of saccular aneurysms increases with aneurysm size, large aneurysms seen during medical or surgical evaluation are usually treated. Ruptured saccular aneurysms are almost always treated when possible. Saccular aneurysms may be treated by surgery to place surgical clips to remove the saccular aneurysm from the bloodstream, or may be preferentially treated with minimally invasive catheter-based procedures.

Minimally invasive catheter-based endovascular devices and procedures have been developed to occlusive, embolize, seal, or reduce blood flow within saccular aneurysms. During certain treatments, small metal wire segments ("coils") are placed in the aneurysm sac to occlude the aneurysm or prevent further expansion and rupture, a procedure known as "coiling". . To treat an aneurysm with a coil, a physician inserts a catheter into the lumen of the vasculature and places the tip of the catheter into the aneurysm sac. With the catheter tip in place, the physician pushes individual coils through the catheter and into the lumen of the aneurysm. During and after treatment, thrombi form in and around the coil, resulting in embolic occlusion of the aneurysm. Over time, the thrombus matures into fibrous tissue, covering the neck of the aneurysm and sealing the aneurysm from the new artery. Although effective, coiling of saccular aneurysms has drawbacks. Coil placement is difficult to control, often resulting in protrusion of the coil into the parent vessel or migration of the coil to non-target locations, and sometimes embolization of the flight defect. Movement of the coil may force the physician to try to retrieve the coil from a non-target location. Many coils are typically required during treatment, resulting in high costs and long treatment times. Furthermore, the coil only partially fills the aneurysm sac. Thrombus and scar tissue must accumulate to completely seal the aneurysm, a process that can take months to years and is often incomplete. Slow aneurysm sealing can reduce the effectiveness of coils in treating acute aneurysm rupture with subarachnoid hemorrhage. Aneurysm sealing after coiling is often incomplete, exposing the patient to a persistent risk of aneurysm rupture and resulting in an unacceptably high retreatment rate. Even if coil use is initially effective, recanalization of the aneurysm occurs, resulting in blood flow returning to the aneurysm and increased risk of rupture. Incomplete filling of saccular aneurysms and inadequate coil sealing of aneurysms is particularly common in the neck region of saccular aneurysms where coil density is low and blood flow velocity is high. Coils are prone to compression, further exposing the aneurysm neck and increasing the rate of aneurysm recurrence.

In some embodiments of the second medical device or first elongated body, the metal is selected and then the coil is oriented from a primary (1°) configuration to a secondary (2°) configuration to a tertiary (3°) configuration. Created by a series of returns to the structure. The primary structure is "stock" wire, which is fabricated in straight form with any range of diameters. Most stock wire used to make coils is in the 0.00175 to 0.003 inch range. The stock wire diameter is a central factor in determining the "stiffness" of the coil. The stock wire is wound around mandrels of various diameters to create a coil secondary structure. The diameter of the secondary structure, along with the number of turns per unit length around the mandrel, represent two additional factors that affect the stiffness of the product. The secondary diameter determines the historical coil grouping, where coils considered "10" coils are typically wound to about 0.010 inches, and coils considered "18" coils are typically wound to about 0.010 inches. , about 0.015 inches. However, many manufacturers now make coils with a second diameter of 0.010 to 0.015 inches, including 0.012 inch and 0.014 inch coil wires. Secondary diameter has important implications for both stiffness and packing damping. Finally, the secondary structure can be shaped into any number of tertiary structures (helical, complex, globular, etc.) and can also be used for specific tertiary diameters and lengths, package labeling and coiling during interventional procedures. It is developed using parameters that act as central factors for selection. For example, coils are typically packaged as "3 mm by 4 cm", where millimeter measurements are tertiary diameter measurements and centimeter measurements are length measurements. Just as metals for coils are readily available, so are manufacturers who can mold them into myriad designs.

Biocompatibility of the first elongated body and the expandable body is very important. The biocompatible first elongated body and expandable body are composed primarily of inert materials to allow effective treatment without concern for systemic host reactions. Metal alloys with a proven record of patient safety have become the primary source for the manufacture of first elongated bodies, expandable bodies and coils. Nitinol, platinum, nickel, iridium, and tungsten are the primary metals used in construction and are usually developed as alloys to reach optimum strength. The strength of metals is determined experimentally and is called the shear modulus or shear modulus. Shear modulus is the modulus of elasticity in shear defined as the ratio of shear stress to shear strain. The shear modulus can be experimentally determined from the slope of the stress-strain curve generated during torsional tests performed on metal samples. A platinum (92%)/tungsten (8%) alloy has become the workhorse material for many current primary elongate body and coil designs. Many metals in pure alloy form are readily available in hundreds of permutations from distributors worldwide.

Recently, traditional tubular stents have been adapted to treat cerebral aneurysms. These stents are placed on a delivery device and placed within the parent vessel adjacent to the aneurysm. The stent is then expanded within the parent vessel using the delivery device, after which the delivery device is removed. An expanded metal stent diverts flow through the aneurysm sac and promotes thrombosis of the aneurysm. Although often effective, these "shunting" stents have drawbacks. First, stents can obscure and divert blood flow from critical arterial branches adjacent to the aneurysm, causing ischemia and stroke. Second, stents can cause thrombus and intimal hyperplasia within the parent vessel, causing thromboembolism and narrowing of the lumen which can lead to ischemia and stroke. Third, long-term anticoagulation is required after stent placement and flow diversion, increasing the risk of hemorrhagic complications and stroke, and in patients who have already experienced aneurysm rupture and subarachnoid hemorrhage. It is contraindicated.

Recently, vascular plugs made of braided or woven Nitinol wire have been indicated for the treatment of cerebral aneurysms. These devices pass through the lumen of the catheter and expand into the aneurysm sac when the catheter guided placement is retracted. The dilation device diverts flow away from the aneurysm sac and facilitates thrombosis of the aneurysm. Although often effective, these "endocystic" devices have drawbacks. First, in the compressed form, the device is stiff and difficult to advance through the tortuous arteries of the cerebral circulation. Second, the majority of device sizes are required to treat many sizes and shapes of aneurysms. Despite the wide selection of sizes offered, the fit between the device and the aneurysm can be sub-optimal increasing the risk of the aneurysm persisting or recurring. Third, endocystic devices are susceptible to compression and compaction that can reopen the aneurysm neck, increasing the risk of aneurysm persistence or recurrence.

Previous attempts have been made to develop and use removable balloons for the treatment of saccular aneurysms. A detachable polymeric balloon coupled to a catheter is advanced into the aneurysm, inflated and removed in an attempt to completely fill and occlude the aneurysm neck and sac. These devices and their associated methods of use suffer from several shortcomings that have been eventually abandoned in favor of other devices and methods. First, balloons often did not completely occlude the aneurysm neck or completely fill the aneurysm sac, increasing the risk of aneurysm persistence or recurrence. Second, balloons have typically been made of flexible polymers such as latex and silicone, which generally resist tissue incorporation. This reduced the fixation of the device to the aneurysm wall and increased the risk of balloon migration and embolization of downstream arterial segments. Third, the balloons were elastic and used valves to maintain the high internal pressure after ablation necessary to maintain their expanded size and shape. Unfortunately, there has been a significant rate of valve failure resulting in balloon deflation leading to aneurysm recanalization and balloon migration.

A medical device, catheter-based medical device, system, and for effectively and reliably occluding, embolizing, sealing, or reducing blood flow in an occlusive embolism, seal, or saccular aneurysm, including a cerebral aneurysm. There remains an unmet clinical need for methods. The device should be low profile, highly flexible, easy to use, and capable of being rapidly and precisely placed. Moreover, the devices are reasonably costly, require limited sizes and numbers to treat most aneurysms, and can be used immediately with one or several devices to reduce the need for chronic anticoagulation. and complete aneurysm neck and sac occlusion must be achieved. Finally, the device should provide durable and permanent occlusion and sealing of saccular aneurysms with low deflation, compression, or compaction of the device and low rates of aneurysm persistence or recanalization.

In certain clinical situations, patients can benefit from an occlusion, embolism, or seal in an artery or arterial segment and reduced blood flow. Clinical situations in which intravascular artery occlusion is beneficial include bleeding from damaged blood vessels, reduced blood flow to tumors, and segregation of abnormalities and malformations due to altered blood pathways within the vasculature. Accordingly, minimally invasive catheter-based endovascular treatments have been developed to occlude arteries and arterial segments.

Medical devices for intravascular arterial occlusion include a coil that can be pushed through a catheter (ie, a "pushable coil") that is deposited into the lumen of the target arterial segment. There are advantages to using coils for arterial occlusion. The device is flexible and can be easily advanced into very long, narrow, small, distal and tortuous vessels. They are also relatively inexpensive. However, like their use in saccular aneurysms, they have drawbacks. Precise placement of the coil within the artery is difficult, and misplacement, migration, and non-target embolization are common. Because they present a porous barrier to blood flow, many coils are often required for complete arterial occlusion, leading to increased treatment time and cost. Slow recanalization or reopening of the treated arterial segment is common with coiling.

Intravascular medical devices for arterial occlusion also include self-expanding vascular plugs that can be pushed through a catheter and deposited into the lumen of a target arterial segment. There are advantages to using vascular plugs for arterial occlusion. Devices can be placed with greater precision than coils. Also, a single device often requires only a single device for arterial occlusion, reducing treatment complexity. However, like coils, there are drawbacks. Devices are often difficult to place in stiff, small, distal, and tortuous arteries, which can increase the time required for the device to completely occlude the artery. They also show slow recanalization of frequently treated arterial segments.

Previous attempts have been made to develop and use removable balloons for arterial occlusion, in which a polymeric balloon is inflated to fill the lumen of the target arterial segment and removed from the catheter. A conformable removable polymeric balloon coupled to a catheter is advanced into the target arterial segment, inflated and withdrawn in an attempt to completely fill and occlude the arterial segment. There are two major advantages of using a detachable balloon catheter for arterial occlusion. First, these devices have a low profile and are very flexible, allowing treatment of small, distal, and tortuous arteries. Second, after inflation, expandable and conformable balloons generally conform well to surrounding vessel wall irregularities, often providing a good seal against the arterial wall and good acute occlusion performance. do. However, these devices and associated methods of use have several drawbacks and are largely abandoned in favor of other devices and methods. First, devices are typically made from compatible polymers such as latex and silicone, which generally resist tissue uptake. Decreased fixation of the device to the arterial wall increases the risk of balloon migration. Second, the balloon is elastic and uses a valve to maintain the high internal pressure after detachment necessary to maintain its expanded size and shape. Unfortunately, there is a substantial percentage of valve failures that result in deflation of the balloon, often resulting in recanalization of the treated artery segment, increasing the risk of balloon migration. Third, the polymers used to manufacture the balloon are biodegradable in vivo. Balloon wall disruption increases the risk of balloon deflation and recanalization of the treated arterial segment.

There is an unmet clinical need for medical devices, catheter-based medical devices, systems, and methods that efficiently and reliably embolize, seal, or reduce blood flow within arteries and arterial segments. Devices are needed that are low profile, highly flexible, easy to use, and capable of rapid and precise placement. Additionally, the device should have a reasonable cost and provide immediate and complete arterial occlusion with one or several devices requiring a limited number of sizes and shapes that occlude most arteries. . Finally, the device should provide durable and permanent occlusion and sealing of saccular aneurysms with low rates of device deflation, compression, compaction and migration and low rates of recanalization of the aneurysm. .

The left atrial appendage (LAA) is a small, sac-like process in the muscular wall of the left atrium. LAA is generally regarded as a vestigial structure and has no definite function. In a normal heart, the heart contracts with each beat. During left atrial contraction, left atrium and LAA blood is ejected into the left ventricle. Electrical impulses control the timing of the heart's various ventricular beats. If these impulses are not delivered in an orderly manner, rapid and chaotic impulses can occur, reducing coordination of atrial contractions and limiting the expulsion of blood from the left atrium and LAA, resulting in an estimated 2.7 million It is a condition known as atrial fibrillation that affects Americans. Blood flow in the left atrium and LAA of patients with atrial fibrillation is slow, increasing the risk of thrombus formation. When thrombi form in the LAA, they break free from the walls of the LAA and are pumped out of the heart. As a result, people with atrial fibrillation are five to seven times more likely to have a stroke than the general population. Patients with atrial fibrillation who are at risk of developing thrombi in the left atrium and LAA may take blood thinners to reduce their stroke risk. Patients who are contraindicated to taking blood thinners, or who do not want to take blood thinners chronically, may be well on their way to sealing the LAA, thereby reducing the risk of stroke and improving blood flow. You don't need to take medicines to thin your skin. Boston Scientific has developed a catheter delivery device, Watchman, to occlude and seal the LAA. Although effective in reducing stroke in patients with atrial fibrillation, patients undergoing Watchman in clinical trials had a higher than expected rate of embolic stroke. Also, doctors were unable to implant Watchman in some patients who had been assigned to obtain the device.

Some patients with atrial fibrillation may benefit from embolization, occlusion, sealing, or reducing blood flow within their LAA. Clinical settings where occlusion of the LAA is beneficial include reducing the risk of embolic stroke in atrial fibrillation patients in whom chronic anticoagulation is contraindicated. Medical devices and methods have been developed for minimally invasive, catheter-based occlusion of the LAA. Currently available devices generally comprise a porous cover over an accident-expandable metal cage with retaining hooks. Although effective, these devices have drawbacks. Porous covers permeate into and out of the LAA, increasing the risk of thrombus formation on the device. Cage support structures are rigid when compressed, making advancement of the device into the LAA more difficult. When expanded, they are rigid and may not optimally conform to the wide variety of shapes of the LAA. A gap between the device and the wall of the LAA allows thrombi to escape around the expanded device, which can also cause stroke. The outer diameter of the delivery system or the compressed, fabric-covered metal cage is large and requires a large hole through the interatrial septum to gain access to the left atrium from venous access. A hole left in the atrial septum after treatment may heal slowly, resulting in a persistent shunting of blood from left to right, increasing the work done by the heart. The perforation also increases the risk of a paradoxical embolism of a thrombus from the right atrium entering the left atrium and subsequently reaching the arterial circulation.

There remains an unmet clinical need for medical devices, catheter-based medical devices, systems, and methods to effectively and reliably occlude, embolize, seal, or reduce blood flow within the LAA. The device should be low profile, highly flexible, easy to use, and capable of being quickly and accurately placed. Furthermore, the device provides immediate and complete occlusion of the LAA, presents a tight, well-cleaned surface to the left atrium, and readily endothelializes, resulting in a durable and permanent high occlusion rate of the LAA.

In certain clinical situations, patients can benefit from vein or vein segment occlusion, embolization, sealing and reduced blood flow. Clinical situations in which intravascular venous occlusion is beneficial include damaged vessels such as bleeding esophageal varices, painful veins such as pelvic varices, and rerouting of blood pathways within the vasculature. Isolate abnormalities and malformations of Accordingly, minimally invasive, catheter-based endovascular treatments have been developed to occlude veins and vein segments.

A medical device for intravascular venous occlusion is delivered via a catheter and includes a pushable coil deposited in the lumen of a target vein segment. There are advantages to using a venous occlusive coil. The devices are flexible and facilitate them for advancement into highly elongated, small, distal, and tortuous vessels. They are also relatively inexpensive. However, as with its use in arteries, precise placement of coils in veins is difficult, and misplacement, migration, and non-target embolization are common. Device migration is particularly common in veins as the diameter of the vein increases from distal to proximal. When the coil is placed in a vein, it becomes free and easy to travel long distances. Coils that travel in veins often become critical structures such as the right atrium, right ventricle, or pulmonary artery.
Because they present a porous barrier to blood flow, multiple coils are often required for complete venous embolization, resulting in increased treatment time and cost. Finally, slow recanalization of treated vein segments is also common.

Intravascular medical devices for venous occlusion also include self-expanding vascular plugs that can be pushed through a catheter and deposited in the lumen of a segment of a target vein. There are advantages to using vascular plugs for venous occlusion. Devices can be placed with greater precision than coils. Also, a single device is often all that is needed for venous occlusion, reducing treatment complexity. However, like coils, there are drawbacks. Devices are often difficult to place in stiff, small, distal, and tortuous veins. Vascular plugs, like coils, present a porous barrier to blood flow and can increase the time required for the device to fully occlude the vein. They also often exhibit slow recanalization of treated venous segments. As with coils, migration is also common, and intravenously placed coils often remain in critical structures such as the right atrium, right ventricle, or pulmonary artery.

Previous attempts have been made to develop and use removable balloons for venous occlusion, in which the polymeric balloon is inflated to fill the lumen of the target vein and removed from the catheter. A catheter-coupled, compatible removable polymeric balloon is advanced into a segment of a target vein, inflated, and withdrawn in an attempt to completely fill and occlude the segment. There are two major advantages of using a detachable balloon catheter for venous occlusion. First, these devices have a low profile and are very flexible, allowing treatment of small, distal and tortuous veins. Second, after expansion, an expandable, conformable balloon generally conforms well to irregularities around the vessel wall, often providing good acute occlusion performance and an excellent seal against the venous wall. However, these devices and associated methods of use have several drawbacks and have largely been abandoned in favor of other devices and methods. First, the devices are usually made from compatible polymers such as latex and silicone, which generally resist tissue integration. Decreased fixation of the device to the vein wall increases the risk of balloon migration. Second, the balloon is elastic and uses a valve to maintain the high internal pressure after detachment necessary to maintain its expanded size and shape. Unfortunately, there is a substantial percentage of valve failures that result in deflation of the balloon, often resulting in recanalization or reopening of the treated vein segment, increasing the risk of balloon migration. Migration is common, as are coils and vascular plugs, and removable balloons placed intravenously often remain in critical structures such as the right atrium, right ventricle, or pulmonary artery. Third, the polymers used to manufacture the balloon are biodegradable in vivo. Balloon wall disruption increases the risk of balloon deflation and recanalization or reopening of the treated vein segment.

There is an unmet clinical need for medical devices, catheter-based medical devices, systems, and methods to efficiently and reliably occlude, embolize, seal and reduce blood flow in veins and vein segments. The device should be low profile, highly flexible, easy to use, and capable of being rapidly and precisely placed. In addition, the device must provide immediate and complete venous occlusion with one or several devices having reasonable cost and requiring mostly limited sizes and shapes to occlude most veins. Finally, the device should provide durable, permanent occlusion of the vein with low rates of device deflation, compression, compaction or migration and low rates of recanalization of the treated vein segment. .

Valves within the heart can become occluded and leak, resulting in reduced cardiac output, increased cardiac load, or both. These faulty valves can be repaired or replaced either intraoperatively or during minimally invasive procedures. After valve repair and replacement, new leaks may develop in areas adjacent to the valve, which can reduce cardiac output and increase the work of the heart. These leaks can also lead to blood damage, including hemolysis of red blood cells that can cause kidney damage and cause anemia. Patients who develop these "paravalvular leaks" can benefit from occlusion of the leak pathways, improving cardiac output, reducing heart strain, and reducing blood damage. Currently, there are no medical devices specifically approved for the treatment of paravalvular leaks. Physicians sometimes use self-expanding vascular plugs that can be pushed through the catheter and deposited within the lumen of the paravalvular leak path to occlude it. However, this approach has drawbacks. The device is stiff and difficult to place. They also present a porous surface to the blood flow that prevents some devices from completely occluding the leak path, which can be large and have high blood flow velocities. The irregular porous surface of the device is susceptible to thrombus formation. Subsequent release and embolization of these thrombi can lead to stroke. As with many porous devices, complete endothelialization of the vascular plug is slow and often incomplete, resulting in a persistently increased risk of thrombus formation and thromboembolism.

There remains an unmet clinical need for medical devices, catheter-based medical devices, systems, and methods for effectively and reliably occluding a paravalvular leak. The device must be low profile, highly flexible, easy to use, and capable of rapid and precise placement. Additionally, the device should provide rapid and complete occlusion of the leakage pathway, be resistant to thrombus formation, and have a rapidly endothelializing surface. Finally, the device should provide durable and permanent occlusion of the leak path with low rates of device deflation, compression, or consolidation and recanalization.

In certain clinical situations, patients can benefit from occlusion, embolization, or sealing and reduction of fluid or material flow within biological conduits. Clinical situations in which intravascular conduit occlusion is beneficial include intentional occlusion of the fallopian tubes to prevent pregnancy. Minimally invasive, catheter-based endovascular treatments have been developed to occlude biological conduits.

There remains an unmet clinical need for medical devices, catheter-based medical devices, systems, and methods for effectively and reliably occluding biological conduits. Devices are needed that are low profile, highly flexible, easy to use, and capable of being rapidly and precisely placed. In addition, the device must provide immediate and complete vessel occlusion with one or several devices of reasonable cost and require a limited size and shape to occlude most conduits. Finally, the device should provide durable, permanent occlusion of the duct with a low rate of device deflation, compression, compaction or migration and a low rate of recanalization of the treated duct segment. . Examples of biological conduits are arteries, veins, thoracic ducts, lymphatics, pancreatic ducts, bile ducts, fallopian tubes, bronchi in humans that carry biological fluids and suspensions, solid or semi-solid biological substances, gases, or air. , ureter, urethra, esophagus, duodenum, jejunum, ileum, colon, seminiferous duct, salivary duct, parotid duct, mammary duct, Schlemm's duct, lacrimal and nasolacrimal duct, cerebral aqueduct, peripheral nerve sheath, and other tubular Including structures or channels. Examples of biological fluids, solid or semi-solid biological substances, gases, or air are blood, lymph, cerebrospinal fluid, urine, bile, pancreatic juice, saliva, milk, tears, aqueous humor, eggs, semen, pulmonary secretions. , food, water, faeces, exhaled air, or exhaled breath.

There is an unmet clinical need for medical devices, catheter-based medical devices, systems, and methods for effectively and reliably positioning balloons, elongate bodies, and expandable bodies in biological space. . Devices must be low profile, highly flexible, easy to use, capable of rapid and precise placement, and resistant to deflation, compression, compaction or migration. As used herein, biological space can refer to a contiguous area or expanse in a human patient, including free, available, or unoccupied contiguous areas or expanses. .

Additionally, methods of manufacturing medical devices for the treatment, occlusion, or sealing of saccular aneurysms (including cerebral aneurysms), arteries, veins, other hollow blood vessels or blood-containing structures, or biological conduits or spaces. and such medical devices include removable polymeric balloons, removable metallic balloons, removable polymer-coated metallic balloons (fully polymer-coated metallic balloons, and partially polymer-coated metallic balloons). metal balloons), and removable metallized polymer balloons (including fully metallized polymer balloons and partially metallized polymer balloons). The balloon is then expandable to fill a void at a target location, and a detachable balloon medical device capable of delivery through the lumen of an artery, vein, blood-containing structure, or biological conduit or space should be manufactured. The balloon remains flexible and can be inflated to fill the void at the target location and then removed from the delivery device, catheter, catheter assembly, and the balloon is valved to maintain inflation pressure within the balloon. or remain in an expanded or partially expanded configuration without the need for other devices. A further need remains for manufacturing a removable balloon medical device that has acceptable biocompatibility, reduces the risk of balloon migration, and reduces the risk of tissue migration to the balloon wall. A textured or microtextured surface is optionally used to facilitate incorporation. Metallized polymer balloons for such medical devices by applying metal to the surface of the polymer balloon by mechanical processes such as wire wrapping, electrochemical processes such as electroplating, electroforming, sputtering, or combinations thereof. There remains a need to manufacture It can also be delivered through the lumen of a second catheter of a (first) medical device that includes a removable balloon and can be used for aneurysms, arteries, veins, LAA, paravalvular leak pathways, blood-containing structures, biological conduits, or removable There also remains a need to manufacture medical devices comprising elongated or expandable bodies that can be used to fill voids at target locations, either in the central void or interior volume of the balloon.

The present invention can be used to occlude, seal, or reduce blood or other biological fluids within saccular aneurysms, arteries, veins, left atrial appendages (LAA), perivalvular leaks, other blood-containing structures, biological conduits, or biological spaces. and medical devices comprising detachable balloon catheters or catheter assemblies for and uses of these medical devices. The detachable balloon of the detachable balloon catheter may comprise a polymeric balloon, a metallic balloon, a polymer-coated metallic balloon, or a metallized polymeric balloon. The present disclosure also relates to medical devices comprising elongated or expanded bodies, and their use with medical devices comprising removable balloons and catheters or catheter assemblies, one or more elongated or expandable A solid body, or solid fluid, can be passed through a catheter of a medical device comprising a removable balloon or catheter assembly, and a portion of the elongated or expandable body is expanded adjacent the expanded balloon. or in both the expanded balloon and the expanded balloon to maintain the size, shape and position of the expanded balloon.

The present disclosure relates to device components, device methods and systems for delivering and deploying various embodiments of a removable balloon of a removable balloon catheter, the removable balloon being a saccular aneurysm, artery , veins, LAA, perivalvular leak pathways, other blood-containing structures, biological conduits, or biological spaces in place in the expanded state of the removable balloon. Set and configured. The present disclosure also provides device components, devices, methods for delivering and deploying various embodiments of elongated or expanded bodies after deploying and expanding a detachable balloon of a detachable balloon catheter. and system. The elongated or expandable body may be used for attachment and detachment of saccular aneurysms, arteries, veins, LAAs, paravalvular leak pathways, other blood-containing structures, biological conduits, other biological spaces, or removable balloon catheters. Dimensioned and configured to fill or seal at least a portion of the possible balloon to maintain the elongate or expandable body in place in the elongated or expanded state. The present disclosure describes medical devices or device components of specific lengths to enable the various described treatments. The present disclosure also describes devices or device components, including catheters, catheter assemblies, and removable balloons, including removable balloons comprising retention structures to enable the various described treatments. .

The present disclosure overcomes several long-standing limitations of other devices designed for these purposes. Elongated book-like coils for vascular embolization are highly flexible and trackable, can be advanced through tortuous arteries and veins, into small and distal vessels, and embolize a wide range of blood-containing structures. allow formation. However, when used alone, these vascular coil elongated bodies often result in slow or incomplete embolization. Expandable bodies, such as vascular plugs, are generally much stiffer than vascular coils when passage of a catheter is constrained, but present a similarly porous surface to blood flow. The present disclosure is a highly flexible medical device that deploys a balloon at a target location presenting a solid surface to blood or biological fluid flow, followed by one or more flexible elongated or expandable bodies. provides support for the balloon, helps maintain size and shape by resisting deflation, compression, and compaction of the balloon, and, in certain instances, maintains balloon position to support the balloon. help reduce the risk of movement of

The present disclosure provides that the assembly of the expanded balloon and one or more elongated or expanded bodies is highly resistant to deflation, compression, compaction, or migration, such as is produced in vivo. The use of a highly flexible catheter or catheter assembly (also called a "delivery catheter" or "first catheter") to deliver a flexible removable balloon and a highly flexible elongated or expandable body. It describes using the same flexible catheter or catheter assembly for delivery. This disclosure also describes medical devices.
A detachable balloon catheter (also referred to as a "guidewire catheter" or "second catheter") component incorporating a guidewire lumen for directing the passage of an elongated or expandable body to various locations. Moveable and usable, the inflated balloon of the removable balloon catheter remains fixed in position, allowing a second medical device to seal the removable balloon, fixing the position of the removable balloon and allowing movement of the balloon. or maintain the expanded size and shape of the expandable balloon to reduce the risk of balloon deflation, compression, or compaction.

A detachable balloon catheter having structure for guidewire insertion that can be moved independently of the detachable balloon and that can be used to deliver an elongated or expandable body improves device performance while: Reduce the diameter or profile of the overall device. One catheter is configured for guidewire insertion and can move independently of the removable balloon and is also used for delivery of the elongated or expandable body, and another catheter is configured for the removable balloon. A detachable balloon catheter comprising at least two catheter assemblies that retain a catheter assembly also allows the use of mechanical latches that can retain the detachable balloon to the catheter assembly. The removable balloon remains attached to the delivery catheter when the guidewire catheter is within the mechanical latch. The removable balloon can be separated from the delivery catheter when the guidewire catheter is retracted from the mechanical latch.

The combination of these different elements creates a removable balloon catheter. Immediate and complete occlusion of arteries, veins, and other blood-containing structures and other biological conduits when used with one or more elongated or expandable bodies to create a low profile, highly flexible system provides simple and immediate mechanical detachment of the expanded and supported balloon from the catheter assembly, resulting in a detachable balloon and coil assembly that is highly resistant to folding, compression, compaction, or migration.

The polymer balloon may comprise a single continuous layer of polymer, except for openings at the proximal and distal ends. The polymeric balloon may further comprise one or more non-metallic coatings, including coatings on the exterior surface. The surface of the polymer balloon has been modified to improve biocompatibility, to promote endothelialization of the blood-contacting surface, and to roughen the surface texture to reduce the risk of balloon migration after placement in vivo. , to smooth the texture of the surface to reduce biomolecule or cell adhesion and to reduce tissue damage after placement in vivo, or after placement in vivo, between the balloon and the surrounding tissue. may be modified to increase the strength of the bond made. Surface modification may include plasma etching, surface roughening or smoothing, alteration of surface chemistry, attachment of molecules or biomolecules, or various combinations of these methods.

A polymeric balloon may comprise a proximal neck, a distal neck, or both proximal and distal necks. A metal structure including tubular structures or segments may be coupled to the proximal neck to form a proximal neck assembly. These metal structures may comprise radiopaque metals that are clearly visible under fluoroscopy and may be part of an assembly for attaching the polymeric balloon to a catheter or catheter assembly. may be part of an assembly for removing a polymeric balloon from a first medical device, including a second catheter, to help guide catheters through the central void and interior volume; may help reduce leakage from the first lumen of the first medical device during inflation of the device.

A metallic, polymeric, or metallic and polymeric structure comprising a tubular structure or segment may be joined to the distal neck of the polymeric balloon to form a proximal neck assembly. These metal, polymer, or metal and polymer structures may comprise radiopaque metals that are clearly visible under fluoroscopy and are part of an assembly for attaching a polymer balloon to a catheter or catheter assembly. may be part of an assembly for removing the polymeric balloon from a catheter or catheter assembly, and may assist in guiding the catheter, including the second catheter of the first medical device, in the central void or interior of the balloon. It may pass through the volume or help reduce leakage from the first lumen of the first medical device during inflation of the balloon. A metallic, polymeric, or metallic and polymeric structure comprising tubular structures or segments may be coupled to the distal neck of a polymeric balloon to form a distal neck assembly. These metal structures, polymer structures, or metal and polymer structures may comprise radiopaque metals that are clearly visible under fluoroscopy and are used for attaching the polymer balloon to a catheter or catheter assembly. It may be part of an assembly, may be part of an assembly for removing a polymeric balloon from a catheter or a catheter assembly, may assist in guiding catheters, including a second catheter of a first medical device, and may be part of a balloon. It may pass through a central void or interior volume, or may help reduce leakage from the first lumen of the first medical device during inflation of the balloon.

The metal balloon may comprise a single continuous layer of metal, except for openings at the proximal and distal ends. The surface of the metal balloon is roughened to improve biocompatibility, to promote endothelialization of the blood-contacting surface, and to reduce the risk of balloon migration after placement in vivo. , to smooth the surface texture and reduce adhesion of biomolecules or molecules and to reduce tissue damage after placement in vivo, or between the balloon and surrounding tissue after placement in vivo. It may be modified to increase the strength of the bond. Surface modification may include roughening or smoothing the surface, altering the surface chemistry, attaching molecules or biomolecules, or various combinations of these methods.

The metal balloon may comprise a proximal neck, a distal neck, or both proximal and distal necks. A metallic, polymeric, or metallic and polymeric structure comprising tubular structures or segments may be joined with the proximal neck to form a proximal neck assembly. These metal structures, polymer structures, or metal and polymer structures may comprise radiopaque metals that are clearly visible under fluoroscopy and are used for attaching the polymer balloon to a catheter or catheter assembly. It may be part of an assembly, may be part of an assembly for removing a polymeric balloon from a catheter or a catheter assembly, may assist in guiding catheters, including a second catheter of a first medical device, and may be part of a balloon. It may pass through a central void or interior volume, or may help reduce leakage from the first lumen during inflation of the balloon.

A metallic, polymeric, or metallic and polymeric structure comprising tubular structures or segments may be coupled to the distal neck of a metallic balloon to form a distal neck assembly. These metal structures, polymer structures, or metal and polymer structures may comprise radiopaque metals that are clearly visible under fluoroscopy and are used for attaching the polymer balloon to a catheter or catheter assembly. It may be part of an assembly, may be part of an assembly for removing a polymeric balloon from a catheter or a catheter assembly, assists in guiding catheters, including a second catheter of a first medical device, and may be part of a balloon. or may help reduce leakage from the first lumen of the first medical device during inflation of the balloon.

Polymer-coated metal balloons comprise a single continuous layer of metal, with the exception of openings at the proximal and distal ends, and one or more non-metallic coatings are applied to one or more polymer coatings or inner and outer surfaces. or may further comprise layers on the inner and outer surfaces. The surface of the polymer-coated metal balloon promotes endothelialization of the blood-contacting surface to improve biocompatibility, thus roughening the surface texture to reduce the risk of balloon migration after placement in vivo. To increase the strength of the bond between the balloon and the surrounding tissue after placement in vivo, surface modifications include plasma etching, surface roughening or smoothing, changes in surface chemistry, It may involve molecules or biomolecules, or various combinations of these methods.

A polymer-coated metal balloon may comprise a proximal neck, a distal neck, or both proximal and distal necks. A metallic, polymeric, or metallic and polymeric structure comprising tubular structures or segments may be coupled to and joined to the proximal neck to form a proximal neck assembly. These metal structures, polymer structures, or metal and polymer structures may comprise radiopaque metals that are clearly visible under fluoroscopy and are used for attaching the polymer balloon to a catheter or catheter assembly. It may be part of an assembly, may be part of an assembly for removing a polymeric balloon from a catheter or a catheter assembly, may assist in guiding catheters, including a second catheter of a first medical device, and may be part of a balloon. It may pass through a central void or interior volume and may help reduce leakage from the first lumen of the first medical device during inflation of the balloon.

A metallic, polymeric, or metallic and polymeric structure comprising tubular structures or segments may be coupled to the distal neck of a polymer-coated metallic balloon to form a distal neck assembly. These metal structures, polymer structures, or metal and polymer structures may comprise radiopaque metals that are clearly visible under fluoroscopy and for attaching the polymer balloon to a catheter or catheter assembly. and may be part of an assembly for removing a polymeric balloon from a catheter or catheter assembly, assisting in guiding a catheter, including a second catheter, of a first medical device, and the balloon or may help reduce leakage from the first lumen of the first medical device during inflation of the balloon.

The metallized polymer balloon may comprise a single continuous layer of polymer, except for openings at the proximal and distal ends. Metallized polymer balloons may further comprise one or more metal structures, layers or coatings, including discontinuous metal structures, layers or coatings, as well as continuous metal structures, layers or coatings. The metal may be applied to the polymer balloon by sputter coating, vapor deposition, electroplating or electroforming, by applying a metal wire or mesh to the surface of the metal balloon, or various combinations of these methods. The metal wire or mesh may be applied in ring, coil, braid, woven or linear form or combinations thereof. A metal structure, layer, or coating may be present on the external surface, the internal surface, or both the external surface and the internal surface. Among other things, the surface of the metallized polymer balloon has been modified to improve biocompatibility, to roughen the surface texture to promote endothelialization of the blood-contacting surface, and to reduce the risk of balloon migration after placement in vivo. or may be modified to increase the strength of the bond that forms between the balloon and the surrounding tissue after placement in vivo. Surface modification may include plasma etching, roughening or smoothing the surface, altering the surface chemistry, binding molecules or biomolecules, or various combinations of these methods.

The metallized polymer balloon may comprise a proximal neck, a distal neck, or both proximal and distal necks. A metallic, polymeric, or metallic and polymeric structure comprising tubular structures or segments may be coupled to the proximal neck to form a proximal neck assembly. These metal structures, polymer structures, or metal and polymer structures may comprise radiopaque metals that are clearly visible under fluoroscopy and are used for attaching the polymer balloon to a catheter or catheter assembly. It may be part of an assembly, part of a catheter or an assembly for detachment from a catheter assembly, assisting in guiding catheters, including a second catheter of a first medical device, the central void of the balloon or It may pass through the interior volume or help reduce leakage from the first lumen of the first medical device during inflation of the balloon.

A metallic, polymeric, or metallic and polymeric structure comprising tubular structures or segments may be coupled to the distal neck of a metallized polymeric balloon to form a distal neck assembly. These metal structures, polymer structures, or metal and polymer structures may comprise radiopaque metals that are clearly visible under fluoroscopy and are used for attaching the polymer balloon to a catheter or catheter assembly. It may be part of an assembly, may be part of a catheter or an assembly for detachment of a polymer balloon from a catheter assembly, and may assist in guiding catheters, including a second catheter of a first medical device, and may be central to the balloon. It may pass through a void or interior volume, or may help reduce leakage from the first lumen of the first medical device during inflation of the balloon.

The present invention presents devices, systems and methods for reducing blood flow within an occlusive embolism, or saccular aneurysm, over an elongated or expandable body on or adjacent to an expanded balloon. Located within both central voids within the central void of the inflated balloon and adjacent to the inflated balloon.

Detachable polymeric balloons, metallic balloons, polymer-coated metallic balloons, and metallized balloons are described wherein the balloons are pleated and foldable to a low profile with a low compatibility polymeric material such as polyethylene terephthalate (PET). Made of accessible gold-like materials, it is highly flexible, expands at low pressure, and provides rapid endothelialization on blood-contacting surfaces as well as rapid tissue to surrounding aneurysms on non-blood-contacting surfaces. Facilitates incorporation and colonization. Polymer balloons, metal balloons, polymer-coated metal balloons, and metallized polymer balloons can be modified to promote attachment to the adjacent aneurysm wall and slow balloon migration in vivo. Elongated bodies, such as coils, can be modified for use with polymeric balloons, metallic balloons, polymer-coated metallic balloons, and metallized polymeric balloons. These elongated bodies may be configured in straight or near-straight, soft, flexible configurations to treat a wide range of sizes and shapes in aneurysms with a relatively small number of balloon and coil sizes and shapes. To do so, one or several long, straight, or nearly straight coils can be used ancillary.

A flexible, low profile catheter or catheter assembly is disclosed herein that can be used to deliver both detachable balloons and coils to aneurysms. Such a catheter assembly comprises a second catheter configured to receive both the guidewire and the coil, which can be forward or forward while the expandable balloon remains fixed in place. You can move it backwards. This feature provides the advantages of over-the-wire delivery along with the ability to precisely place the coil both adjacent the expanded removable balloon and inside the expanded removable balloon. As a result, the aneurysm neck and sac can be embolized immediately and completely in vivo and without the need for increased pressure within the balloon or valve to maintain that pressure without degradation, migration, or migration. A detachable and implantable balloon and coil assembly is provided that can maintain its occlusion over time by resisting deflation, compression or compaction.

In one example, a pleated and folded gold metal balloon is inserted with a first catheter and guidewire coupled or operably joined to the balloon to deliver an elongated or expandable body. The two catheter assembly of the configured second catheter is used to advance over the aneurysm guidewire and into the aneurysm sac. Fluid is injected under pressure from the hub of the first catheter through the first lumen and into the central void of the balloon, causing expansion of the balloon. The first catheter is then used to pull back the inflated balloon until it is pressed against the neck of the aneurysm. A second catheter is then advanced over the guidewire to the aneurysm lumen or sac, the guidewire is removed, and an elongated body (also called a "vascular coil") approximately 100 cm long is passed through the lumen of the second catheter. Advance into the aneurysm sac behind the inflated balloon. Some segments of the vascular coil contact the inner surface of the aneurysm wall and the outer surface of the aneurysm wall. The loops of the vascular coil exert a force on the wall of the dilated balloon in a direction toward the aneurysm neck to help seal the aneurysm neck and reduce the risk of migration or movement of the dilated balloon. After confirming the correct position of the balloon and proper occlusion of the aneurysm neck and sac, the vascular coil is removed from its delivery system, the inflated balloon is removed from the catheter, and the catheter is removed along with the vascular coil delivery system. Vascular coil detachment may occur by mechanical, electrolytic, or electrothermal means. In this example, the gold metal balloon can withstand deflation, compression, or compaction without placing additional support material within the central void of the balloon. Using the above approach, multiple elongated bodies, expandable bodies or vascular coils can be placed in the aneurysm sac behind the expanded balloon at any time prior to removal of the balloon from the first catheter.

In another example, a pleated, folded polymeric balloon is configured for insertion of a first catheter and guidewire coupled or operably joined to the balloon and for delivery of an elongated or expandable body. The two catheter assembly of the second catheter is used to advance over the guidewire to the aneurysm sac. Fluid is injected under pressure through the first lumen from the hub of the first catheter into the central void of the balloon, causing expansion of the balloon. The first catheter is then used to pull back the inflated balloon until it presses against the neck of the aneurysm. A second catheter was then advanced over the guidewire into the lumen or sac of the aneurysm, the guidewire was removed, and the distal portion of the vasculature coil elongated body, approximately 100 cm long, passed through the lumen of the second catheter and dilated. Advance through the aneurysm sac behind the balloon. Some segments of the distal portion of the vascular coil contact the inner surface of the aneurysm wall and other segments of the distal portion of the vascular coil contact the outer surface of the wall of the inflated balloon. A force is applied to the outer surface of the wall of the inflated balloon toward the aneurysm neck to help seal the aneurysm neck and reduce the risk of movement or movement of the inflated balloon. The second catheter is then withdrawn until its tip is in the central void of the expanded balloon, and the remaining proximal portion of the vascular coil is positioned within the expandable central void. Some segments of the proximal portion of the vascular coil contact the inner surface of the wall of the inflated balloon. The loops of the vascular coil exert an outward force on the inner surface of the wall of the inflated balloon to help the inflated balloon resist deflation, compression, or compaction, maintain closure of the aneurysm neck, and reduce the pressure on the balloon. Reduce the risk of movement or movement. After confirming occlusion of the aneurysm neck and sac, the vascular coil is separated from its delivery system, the inflated balloon is separated from the first catheter, and the catheter and vascular coil delivery system are removed. Vascular coil detachment may occur by mechanical, electrolytic, or electrothermal means. In some examples, one or more elongate bodies, or vascular coils, are placed in the aneurysm sac, and one or more separate elongate bodies, expandable bodies, or vascular coils are placed in the expanded balloon. In some examples, the balloon is a metallized polymer balloon and an outer layer of gold or titanium is present on the outer surface of the polymer balloon with a thickness of 1 μm. In these instances, the polymer balloon or metallized polymer balloon cannot resist deflation, compression or compaction without additional support material placed within the central void of the balloon.

In another example, after placement of a dilatation balloon at the aneurysm neck and orientation of a single vascular coil, the distal portion of the vascular coil within the aneurysm sac behind the dilated balloon and within the central space of the dilated balloon. With the remaining proximal portion of the vascular coil, the physician concludes that the balloon diameter is too small and the vascular coil length is too short before removing either. The physician then removes the tubular coil from the patient, deflates the balloon by applying a vacuum to the inflation portion of the hub of the first catheter, and removes the balloon from the patient. The physician then selects a larger diameter balloon and a longer vascular coil according to the methods described above, places them in the aneurysm, and ensures that the balloon diameter and coil length are appropriate. , separate the vascular coil and inflated balloon, and remove the catheter and any elongated body delivery system.

The present disclosure presents devices, systems, and methods for occluding, embolizing, or reducing blood flow in arteries, wherein a removable balloon is placed in the lumen of the artery and maintained in an expanded configuration. Optionally, one or more elongated or expanded bodies are disposed both adjacent to the expanded balloon and within the central void of the expanded balloon or adjacent to the expanded balloon and within the central void of the expanded balloon. be done. Detachable polymer balloons, metal balloons, polymer-coated metal balloons, and metallized polymer balloons are described wherein the balloons are made of low conformability polymer materials such as PET and pleated folded low profiles. Made of an accessible metal such as gold, it is highly flexible, expands at low pressures, and facilitates rapid tissue uptake and fixation to the surrounding arterial wall. The outer surface of polymeric, metallic, polymer-coated metallic, and metallized polymeric balloons can be modified to promote adhesion to adjacent arterial walls and reduce the rate of balloon migration in vivo. Elongated bodies, such as coils, can be modified for use with detachable polymer balloons, metal balloons, polymer-coated metal balloons, and metallized polymer balloons. These elongated bodies can be configured in straight or nearly straight, soft and flexible forms, supporting one or a few long, straight or nearly straight coils. used to treat a wide range of artery sizes with a relatively small number of balloon and coil sizes.

Flexible, low profile catheters or catheter assemblies are described herein that can be used to deliver both detachable balloons and coils to target arterial segments. Such a catheter assembly comprises a second catheter configured to receive both the guidewire and the coil such that the expandable removable balloon remains fixed in place while the second catheter is forward or forward. You can move it backwards. This feature provides the advantages of over-the-wire delivery along with the ability to precisely place the coil both adjacent the expanded removable balloon and inside the expanded removable balloon. As a result, the artery can be embolized immediately and completely in vivo and without the need to increase pressure within the balloon or valve to maintain that pressure without deteriorating, migrating, deflating, compressing or A removable and implantable balloon and coil assembly is provided that can maintain its occlusion by resisting compaction.

In one example, a pleated and folded gold metal balloon is attached to two catheters, a first catheter coupled or operably joined to the balloon and a second catheter configured for guidewire insertion. A catheter assembly is used to advance over the guidewire to the selected arterial segment. Fluid is injected under pressure from the hub of the first catheter through the first lumen and into the central void of the balloon, causing expansion of the balloon. After confirming correct placement of the balloon and proper occlusion of the selected arterial segment, the inflated balloon is removed from the first catheter and the guidewire and catheter are removed from the patient. Detachment may occur by mechanical, electrolytic, or electrothermal means. In this example, the gold metal balloon can resist deflation, compression, or compaction without additional support material placed inside the central void of the balloon.

In another example, a pleated, folded polymeric balloon is configured for insertion of a guidewire and delivery of an elongated or expandable body with a first catheter coupled or operably joined to the balloon. A two-catheter assembly with a second catheter is used to advance over the guidewire to the selected arterial segment. Fluid is injected from the hub of the first catheter through the first lumen and into the central void of the balloon, causing expansion of the balloon. After confirming correct placement of the balloon and proper occlusion of the selected arterial segment, the physician removes the guidewire and pulls back the second catheter until its tip is within the central void of the inflated balloon. The physician then places the elongated body of the vascular coil through the lumen of the second catheter and into the central void of the expandable balloon. Some segments of the vascular coil contact the inner surface of the wall of the inflated balloon. The loops of the vascular coil are expanded to help the expanded balloon resist deflation, compression, or compaction, to maintain occlusion of the arterial segment, and to reduce the risk of movement or migration of the balloon. exerts an outward force on the inner surface of the balloon. After confirming occlusion of the selected arterial segment, the vascular coil is removed from its delivery system and the inflated balloon is removed. Detachment may occur by mechanical, electrolytic or electrothermal means. In some examples, more than one elongated body, expandable body, or vascular coil is disposed on the expanded balloon. In some examples, the balloon comprises a distal neck assembly having an elastomeric or male valve that closes the distal opening of the balloon after retraction of the guidewire and second catheter. In addition to providing hemostasis within the expandable balloon, the valve may provide the primary means of attaching the balloon to the second catheter or assembly of first and second catheters.

In some examples, the distal portion of the elongated body, expandable body, or vascular coil is placed in the distal arterial lumen of the expanded polymeric balloon, and the proximal portion of the elongated body, expandable body, or vascular coil is placed in the distal arterial lumen. The section is positioned in the central void of the expanded balloon to close at least a portion of the distal opening of the balloon. less than the thickness present on the outer surface of the polymer balloon. In these instances, the polymer balloon or metallized polymer balloon cannot resist deflation, compression or compaction without additional support material placed within the central void of the balloon.

The present disclosure presents devices, systems, and methods for occluding, embolizing, or reducing blood flow in a vein, wherein a removable balloon is placed in the lumen of the vein and maintained in an expanded configuration. Optionally, one or more elongated or expandable bodies are disposed in the expanded balloon, within the central void of each tying balloon, or in both the adjacent expanded balloon and the central void of the expanded balloon. Detachable polymer balloons, metal balloons, polymer-coated metal balloons, and metallized polymer balloons are described wherein the balloons are pleated and folded to a low profile with less compatible polymer materials such as PET. It is made of a metal such as gold that achieves high flexibility, low pressure expansion, and promotes rapid tissue integration and fixation to the surrounding vein wall. The exterior surfaces of polymeric, metallic, polymer-coated metallic, and metallized polymeric balloons are modified to promote adhesion to adjacent tissue walls and reduce the rate of balloon migration in vivo. A self-expanding structure may be added to the proximal or distal neck of the balloon, the self-expanding structure contacting the walls of adjacent vein segments to reduce the risk of balloon migration. Elongated bodies such as coils can be used with detachable polymer balloons, metal balloons, polymer-coated metal balloons, and metallized polymer balloons. These elongated bodies can be constructed in a straight, flexible, flexible form, and can be relatively thin with the help of one or a few long, straight, or nearly straight coils. To treat a wide range of vein sizes with a small number of balloon and coil sizes.

Flexible, low profile catheters or catheter assemblies are described herein and are used to deliver both detachable balloons and coils to target vein segments. Such a catheter assembly is a second catheter configured to receive both a guidewire and a coil, with the inflated removable balloon remaining fixed in place, the shaft being able to move forwards or backwards. can be moved. This feature provides the advantages of over-the-wire delivery along with the ability to precisely place the coil both adjacent the expanded detachable balloon and within the expanded detachable balloon. As a result, the vein can be completely occluded in vivo quickly and without the need to increase the pressure within the balloon or valve to maintain that pressure without deterioration, migration, deflation, compression or consolidation. A removable, implantable balloon and coil assembly that can be resisted to maintain its occlusion for an extended period of time.

In one example, a pleated and folded gold metal balloon is attached to a first catheter coupled or operably joined to the balloon, a second catheter configured for insertion of a guidewire, and the balloon. A selected vein segment is advanced using a three catheter assembly with a third catheter configured to constrain a self-expanding retention structure coupled to the proximal or distal neck. The third catheter is withdrawn while the balloon is held in place, causing the self-expanding retention structure to expand and a portion of the retention structure to engage the wall of the vein. Fluid is injected under pressure from the hub of the first catheter through the first lumen and into the central void of the balloon, causing expansion of the balloon. After confirming correct placement of the balloon and proper occlusion of the selected vein segment, the inflated balloon is removed from the first catheter and the guidewire and catheter are removed. Detachment may occur by mechanical, electrolytic, or electrothermal means. In this example, the gold metal balloon can resist deflation, compression, or compaction without placing additional support material within the central void of the balloon.

In another example, a pleated and folded polymeric balloon is placed on three catheters: a first catheter joined or operatively connected to the balloon, a second catheter configured for guidewire insertion. , and a third catheter assembly configured to constrain a self-expanding retention structure joined to the distal or proximal neck of the balloon over the guidewire and into the selected vein segment. move forward. Leaving the balloon in place, the third catheter is retracted, resulting in expansion of the self-expanding retention structure and engagement of a portion of the retention structure with the vessel wall. Fluid is infused under pressure from the hub of the first catheter, through the first lumen, and into the central void of the balloon to expand the balloon. After confirming correct placement of the balloon and proper occlusion of the selected vein segment, the physician removes the guidewire and pulls back the second catheter until its tip is in the central void of the expanded balloon. The physician then places the vascular coil elongated body through the lumen of the second catheter and into the central void of the expandable balloon. Some segments of the vascular coil contact the inner surface of the wall of the inflated balloon. Loops of the vascular coil may be used to help the inflated balloon resist deflation, compression, or compaction, to maintain venous segment occlusion, to reduce the risk of balloon movement or migration, and to reduce the risk of balloon movement or migration. It exerts an outward force on the inner surface of the wall. After confirming occlusion of the selected vein segment, the vascular coil is removed from its delivery system, the inflated balloon is removed from the first catheter, and the catheter and vascular coil delivery system are removed. Separation may be by mechanical, electrolytic or electrical means. In some examples, multiple elongated bodies, expandable bodies, or vascular coils are placed within the expanded balloon. In some examples, the balloon includes a distal neck assembly having an elastomeric or resilient valve that closes the distal opening in the balloon after the guidewire and second catheter have been pulled back. In addition to providing hemostasis within the expandable balloon, the valve provides the primary means for attaching the balloon to the second catheter, the first catheter, or the assembly of the first and second catheters. may

In some examples, the distal portion of the elongated body, expandable body, or vascular coil is positioned in the vein distal to the expanded balloon to occlude at least a portion of the distal opening of the balloon. Placed in the lumen and the proximal portion of the elongated body, expandable body, or vascular coil placed in the central void of the expanded balloon. In some examples, the retention structure is joined to the proximal neck of the balloon and in other examples the retention structure is joined to the distal neck of the balloon. In some examples, the balloon is a metallized polymer balloon with an outer layer of gold or titanium no greater than 1 μm thick on the outer surface of the polymer balloon. In these instances, the polymer or metallized polymer balloon cannot withstand deflation, compression, or compaction without additional support material placed within the central void of the balloon.

The present disclosure provides devices, systems and methods for occluding, embolizing, or reducing blood flow within the left atrial appendage by placing a removable balloon in the lumen of the left atrial appendage and maintaining it there in an expanded configuration. do. Optionally, one or more elongated or expandable bodies are adjacent to the expanded balloon, within the central void of the expanded balloon, or adjacent to the expanded balloon and centrally of the expanded balloon. Located both inside the void. Detachable polymer balloons, metal balloons, polymer-coated metal balloons, and metallized polymer balloons are made of low-compliance polymer materials such as PET or gold, which can be pleated and folded to achieve a low profile. metal, is highly flexible, expands at low pressures, and facilitates rapid tissue uptake and fixation to the surrounding wall of the left atrial appendage. The exterior surface of polymeric, metallic, polymer-coated metallic, and metallized polymeric balloons can be modified to facilitate attachment to the adjacent left atrial appendage wall and to reduce the rate of balloon migration in vivo. can be done. Elongated bodies such as coils can be modified for use with detachable polymer balloons, metal balloons, polymer-coated metal balloons, and metallized polymer balloons. These elongated bodies can be configured in straight or nearly straight, soft, flexible configurations to treat a range of left atrial appendage sizes with relatively few balloons and relatively small coil sizes. It allows the auxiliary use of one or a few long, straight or nearly straight coils for the purpose.

A flexible, low profile catheter or catheter assembly, which can be used to deliver both detachable balloons and coils to the left atrial appendage, is disclosed herein. Such a catheter assembly includes a second catheter configured to receive both the guidewire and the coil, and is forwardly positioned while the inflated removable balloon remains fixed in place. or posteriorly, thereby allowing for over-the-wire delivery, along with the ability to precisely position the coil both adjacent to and within the expanded removable balloon. provide an advantage. As a result, the left atrial appendage can be immediately and completely occluded in vivo, without the need for high pressure inside the balloon or a valve to maintain that pressure, and can be used over time by resisting degradation, migration, deflation, and compression. A detachable, implantable balloon and coil assembly capable of effectively maintaining the occlusion.

In one example, a pleated and folded gold metal balloon is attached to three catheters: a first catheter bonded or operably coupled to the balloon, a second catheter configured for guidewire insertion. , and a third catheter assembly configured to constrain a self-expanding retention structure joined to the distal or proximal neck of the balloon, over the guidewire and into the left atrial appendage. Leaving the balloon in place, the third catheter is retracted, resulting in expansion of the self-expanding retention structure and engagement of a portion of the retention structure with the wall of the left atrial appendage. Fluid is infused under pressure from the hub of the first catheter, through the first lumen, and into the central void of the balloon to expand the balloon. After confirming correct placement of the balloon and adequate occlusion of the left atrial appendage, the inflated balloon is detached from the first catheter and guidewire, and the catheter is removed. Separation may be by mechanical, electrolytic or electrical means. In this example, the gold metal balloon can withstand deflation, compression, or compaction without additional support material placed inside the central void of the balloon.

In another example, a pleated and folded polymeric balloon is placed on three catheters: a first catheter joined or operably coupled to the balloon, a second catheter configured for guidewire insertion, and a third catheter assembly configured to constrain a self-expanding retention structure joined to the distal neck of the balloon and advanced over the guidewire into the left atrial appendage. Leaving the balloon in place, the third catheter is retracted, resulting in expansion of the self-expanding retention structure joined to the balloon and engagement of a portion of said retention structure with the wall of the left atrial appendage. bring. Fluid is infused under pressure from the hub of the first catheter, through the first lumen, and into the central void of the balloon to expand the balloon. After confirming correct placement of the balloon and proper occlusion of the left atrial appendage, the physician removes the guidewire and pulls back the second catheter until its tip is in the central cavity of the expanded balloon. The physician then places the vascular coil elongated body through the lumen of the second catheter and into the central void of the expandable balloon. Some segments of the vascular coil contact the inner surface of the wall of the inflated balloon. Vascular coil loops may be used to help the expanded balloon resist deflation, compression, or compaction, to maintain occlusion of the left atrial appendage, to reduce the risk of balloon movement or migration, and to reduce the risk of balloon movement or migration. It exerts an outward force on the inner surface of the wall. After confirming occlusion of the left atrial appendage, the vascular coil is removed from its delivery system, the inflated balloon is removed from the first catheter, and the catheter and vascular coil delivery system are removed. Separation may be by mechanical, electrolytic or electrical means. In some examples, multiple elongated bodies, expandable bodies, or vascular coils are placed within the expanded balloon. In some examples, the balloon is a metallized polymer balloon with an outer layer of gold or titanium no greater than 1 μm thick on the outer surface of the polymer balloon. In these instances, the polymer or metallized polymer balloon cannot withstand deflation, compression, or compaction without additional support material placed within the central void of the balloon.

SUMMARY OF THE DISCLOSURE Apparatuses, systems for occluding, embolizing, or reducing blood flow in a paravalvular leak pathway, wherein a removable balloon is positioned in the lumen of the paravalvular leak pathway and maintained there in an expanded configuration. and provide a method. Optionally, one or more elongated or expandable bodies are adjacent to the expanded balloon, within the central void of the expanded balloon, or adjacent to the expanded balloon and centrally of the expanded balloon. Located both inside the void. Detachable polymer balloons, metal balloons, polymer-coated metal balloons, and metallized polymer balloons are made of low-compliance polymer materials such as PET or gold, which can be pleated and folded to achieve a low profile. metal, is highly flexible, expands at low pressures, and promotes rapid tissue uptake and anchoring to the surrounding arterial wall. The exterior surface of polymeric, metallic, polymer-coated metallic, and metallized polymeric balloons can be modified to facilitate attachment to adjacent tissue and reduce the rate of balloon migration in vivo. Elongated bodies such as coils can be modified for use with detachable polymer balloons, metal balloons, polymer-coated metal balloons, and metallized polymer balloons. These elongated bodies can be configured in straight or nearly straight, flexible, flexible configurations to treat a wide range of artery sizes with a relatively small number of balloons and relatively small coil sizes. Additionally, it allows the auxiliary use of one or a few long, straight or nearly straight coils.

A flexible, low-profile catheter or catheter assembly, which can be used to deliver both a detachable balloon and a coil to a targeted paravalvular leak pathway, is disclosed herein. Such a catheter assembly includes a second catheter configured to receive both the guidewire and the coil, and is forwardly positioned while the inflated removable balloon remains fixed in place. Or you can move it backwards. This technical feature provides the advantage of over-the-wire delivery in addition to the ability to precisely place the coil both adjacent to and within the expanded detachable balloon. As a result, paravalvular leak pathways can be immediately and completely occluded in vivo without the need for high pressure inside the balloon or a valve to maintain that pressure, and resist degradation, migration, deflation and compression. provides a removable, implantable balloon and coil assembly that can maintain the occlusion over time.

In one example, the pleats are formed and folded such that the distal portion of the balloon is distal to the paravalvular leak path and the proximal portion of the balloon is proximal to the paravalvular leak path. The gold metal balloon, a first catheter operably connected to the balloon, and a second catheter configured for guidewire insertion are then placed until the appropriate length gold metal balloon is positioned. A detachable balloon catheter containing is advanced over the guidewire. Fluid is infused under pressure from the hub of the first catheter, through the first lumen, and into the central void of the balloon to expand the balloon. After confirming correct placement of the balloon and proper occlusion of the leak path, the inflated balloon is detached from the first catheter and guidewire, and the catheter is removed from the patient. Separation may be by mechanical, electrolytic or electrical means. In this example, the gold metal balloon can withstand deflation, compression, or compaction without additional support material placed inside the central void of the balloon.

In another example, the pleats are formed and folded such that the distal portion of the balloon is distal to the paravalvular leak path and the proximal portion of the balloon is proximal to the paravalvular leak path. For insertion and delivery of the polymeric balloon, the first catheter joined or operably coupled to the balloon, and the guidewire and delivery of the elongated or expandable body until the appropriate length of the polymeric balloon is positioned. A detachable balloon catheter, including the configured second catheter, is advanced over the guidewire. Fluid is infused under pressure from the hub of the first catheter, through the first lumen, and into the central void of the balloon to expand the balloon. After confirming correct placement of the balloon and proper occlusion of the paravalvular leak path, the physician removes the guidewire and pulls back the second catheter until its tip is in the central void of the dilated balloon. The physician then places the vascular coil elongated body through the lumen of the second catheter and within the central void of the expandable balloon, with some portion of the vascular coil contacting the inner surface of the wall of the expanded balloon. . The loops of the vascular coil are dilated to help the expanded balloon resist deflation, compression, or compaction, to maintain occlusion of the paravalvular leak pathway, and to reduce the risk of balloon movement or migration. An outward force is exerted on the inner surface of the balloon wall. After confirming occlusion of the paravalvular leak path, the vascular coil is removed from its delivery system, the inflated balloon is removed from the first catheter, and the catheter and vascular coil delivery system are removed. Separation may be by mechanical, electrolytic or electrical means.

In some examples, multiple elongated bodies, expandable bodies or vascular coils are disposed within an expanded balloon. In some examples, the distal portion of the elongate body, expandable body, or vascular coil is positioned distal to the expanded polymeric balloon to occlude at least a portion of the distal opening of the balloon. A proximal portion of the elongated body, expandable body, or vascular coil positioned in the peripheral leakage path is positioned in the central void of the expanded balloon. In some examples, the balloon includes a distal neck assembly having an elastomeric or resilient valve that closes the distal opening in the balloon after the second catheter is pulled back. In some examples, the balloon is a metallized polymer balloon with an outer layer of gold or titanium no greater than 1 μm thick on the outer surface of the polymer balloon. In these instances, the polymer or metallized polymer balloon cannot withstand deflation, compression, or compaction without additional support material placed within the central void of the balloon.

SUMMARY OF THE DISCLOSURE A device for occluding, embolizing, or reducing the flow of a biological fluid or material in a biological conduit comprising placing a removable balloon in the lumen of the biological conduit and maintaining it there in an expanded configuration. , to provide a system and method. Optionally, one or more elongated or expandable bodies are adjacent to the expanded balloon, within the central void of the expanded balloon, or adjacent to the expanded balloon and centrally of the expanded balloon. Located both inside the void. Detachable polymer balloons, metal balloons, polymer-coated metal balloons, and metallized polymer balloons are made of low-compliance polymer materials such as PET or gold, which can be pleated and folded to achieve a low profile. metal, is highly flexible, expands at low pressures, and facilitates rapid tissue uptake and anchoring to the walls of the surrounding biological conduit. The exterior surface of polymeric, metallic, polymer-coated metallic, and metallized polymeric balloons can be modified to facilitate attachment to the walls of adjacent biological conduits and to reduce the rate of balloon migration in vivo. can be done. Elongated bodies such as coils can be modified for use with the removable polymeric, metallic, polymer-coated metallic, and metallized polymeric balloons described herein. These elongated bodies can be configured in a straight, flexible, flexible configuration to provide a single coil for treating a wide range of vessel sizes with a relatively small number of balloons and relatively small coil sizes. Or allows the secondary use of a small number of long, straight or almost straight coils.

Flexible, low-profile catheters or catheter assemblies that can be used to deliver both detachable balloons and coils to targeted biological conduit segments are disclosed herein. Such assemblies include a shaft configured to receive both the guidewire and the coil, which can be moved forward or backward while the inflated removable balloon remains fixed in place. can. This technical feature provides the advantage of over-the-wire delivery in addition to the ability to precisely place the coil both adjacent to and within the expanded detachable balloon. As a result, biological conduits can be immediately and completely occluded in vivo without the need for high pressure inside the balloon or a valve to maintain that pressure, and over time by resisting degradation, migration, deflation and compression. A detachable, implantable balloon and coil assembly capable of effectively maintaining the occlusion.

In one example, a pleated and folded gold metal balloon is attached to three catheters: a first catheter bonded or operably coupled to the balloon, a second catheter configured for guidewire insertion. , and a third catheter configured to constrain a self-expanding retention structure joined to the distal or proximal neck of the balloon, over the guidewire and into the selected biological conduit segment. advance to Leaving the balloon in place, the third catheter is retracted, resulting in expansion of the self-expanding retention structure and engagement of a portion of the retention structure with the wall of the biological conduit. Fluid is infused under pressure from the hub of the first catheter, through the first lumen, and into the central void of the balloon to expand the balloon. After confirming occlusion of the selected biological conduit segment, the inflated balloon is detached from the first catheter and guidewire, and the catheter is removed. Separation may be by mechanical, electrolytic or electrical means. In this example, the gold metal balloon can withstand deflation, compression, or compaction without additional support material placed inside the central void of the balloon.

In another example, a pleated and folded polymeric balloon is placed on three catheters: a first catheter joined or operably coupled to the balloon, a second catheter configured for guidewire insertion, and a third catheter assembly configured to constrain a self-expanding retention structure joined to the distal neck of the balloon and advanced over the guidewire into the selected biological conduit segment. Leaving the balloon in place, the third catheter is retracted, resulting in expansion of the self-expanding retention structure joined to the balloon and engagement of a portion of said retention structure with the wall of the biological conduit. bring. Fluid is infused under pressure from the hub of the first catheter, through the first lumen, and into the central void of the balloon to expand the balloon. After confirming correct placement of the balloon and proper occlusion of the selected body conduit segment, the physician removes the guidewire and pulls back the second catheter until its tip is in the central void of the inflated balloon. The physician then places the elongated body of the vascular coil through the lumen of the second catheter and within the central void of the expandable balloon, with several segments of the proximal portion of the vascular coil extending into the wall of the expanded balloon. contact the inner surface. Vascular coil loops are used to help the expanded balloon resist deflation, compression, or compaction, to maintain occlusion of biological conduit segments, to reduce the risk of balloon movement or migration, and to reduce the risk of balloon movement or migration. exerts an outward force on the inner surface of the wall of the After confirming occlusion of the selected biological conduit segment, the vascular coil is removed from its delivery system, the inflated balloon is removed from the first catheter, and the catheter and vascular coil delivery system are removed. Separation may be by mechanical, electrolytic or electrical means. In some examples, multiple elongated bodies, expandable bodies, or vascular coils are placed within the expanded balloon.

In some examples, multiple elongated bodies, expandable bodies or vascular coils are disposed within an expanded balloon. In some examples, the distal portion of the elongated body, expandable body, or vascular coil is disposed in a biological conduit distal to the expanded balloon to occlude at least a portion of the distal opening of the balloon. A proximal portion of the elongated body, expandable body, or vascular coil disposed therein is disposed in the central void of the expanded balloon. In some examples, the balloon includes a distal neck assembly having an elastomeric or resilient valve that closes the distal opening in the balloon after the second catheter is pulled back.
In some examples, the retention structure is joined to the proximal neck of the balloon and in other examples the retention structure is joined to the distal neck of the balloon. In some examples, the balloon is a metallized polymer balloon with an outer layer of gold or titanium no greater than 1 μm thick on the outer surface of the polymer balloon. In these instances, the polymer or metallized polymer balloon cannot withstand deflation, compression, or compaction without additional support material placed within the central void of the balloon.

The present disclosure also includes detachable polymer balloons, detachable metal balloons, detachable polymer-coated metal balloons (including fully polymer-coated metal balloons and partially polymer-coated metal balloons), and (fully It also relates to the manufacture of removable metallized polymer balloons, including heavily metallized polymer balloons and partially metallized polymer balloons. Methods of applying one or more metals to the surface of a balloon comprising or substantially comprising a polymer such as PET, polyamide (nylon), or polyether block amide (Pebax) include the form of wire coils or other patterns. electrochemical methods such as electroplating, electroforming, or sputtering; or various combinations of mechanical or electrochemical methods.

FIG. 2 is a plan view of one embodiment of a balloon having both proximal and distal necks with defined overall geometric dimensions; FIG. 2 is a plan view of one embodiment of a balloon having both proximal and distal necks with defined overall geometric dimensions; 2A-2D are tables describing ranges of values for the overall geometric dimensions of the balloon embodiment shown in FIG. FIG. 10 is a plan view of another embodiment of a balloon having both proximal and distal necks with defined overall geometric dimensions; FIG. 10 is a plan view of another embodiment of a balloon having both proximal and distal necks with defined overall geometric dimensions; FIG. 4 is a table setting forth value ranges for the overall geometric dimensions of the balloon embodiment shown in FIG. 3; FIG. FIG. 4 is a table setting forth value ranges for the overall geometric dimensions of the balloon embodiment shown in FIG. 3; FIG. FIG. 4 is a table setting forth value ranges for the overall geometric dimensions of the balloon embodiment shown in FIG. 3; FIG. FIG. 4 is a table setting forth value ranges for the overall geometric dimensions of the balloon embodiment shown in FIG. 3; FIG. 2 is a cross-sectional view of the proximal portion of the embodiment of the balloon shown in FIG. 1 with its geometric dimensions defined; FIG. 4 is a cross-sectional view of the proximal portion of the embodiment of the balloon shown in FIG. 3 with its geometric dimensions defined; FIG. 5B is a table illustrating ranges of proximal geometric dimension values for the embodiment of the balloon shown in FIG. 5A. 5B is a table illustrating ranges of proximal geometric dimension values for the embodiment of the balloon shown in FIG. 5A. FIG. 5C is a table setting forth value ranges for the proximal geometric dimensions of the embodiment of the balloon shown in FIG. 5B; FIG. FIG. 5C is a table setting forth value ranges for the proximal geometric dimensions of the embodiment of the balloon shown in FIG. 5B; FIG. FIG. 5 provides cross-sectional views of portions of the outer wall of metal, metallized, polymer, or hybrid balloons showing seven embodiments of layering. 8A-8J are plan views of embodiments of balloons having the shape of the embodiment shown in FIG. 1 incorporating various layer types defined in FIG. 7 in various regions of the balloon. 9A-9L are plan views of embodiments of balloons having the shape of the embodiment shown in FIG. 3 incorporating various layer types defined in FIG. 3 in various regions of the balloon. 10A-10D are cross-sectional views of portions of the outer wall of various embodiments of balloons incorporating single or multiple layers and a smooth or textured outer surface. 11A-11H are partial cross-sectional views of balloons having the shape of the embodiment shown in FIG. 3 incorporating elastic structures within their necks according to eight embodiments. 3 provides a cross-sectional view of a balloon having the shape of the embodiment shown in FIG. 3 incorporating elastic structures in both its proximal and distal necks, demonstrating its ability to trap air bubbles in four different orientations. 13A-13D are plan views showing one embodiment of a detachable balloon delivery system comprising a guidewire and three catheters, including details of the proximal configuration and purpose of each catheter. 14A-14C are top and cross-sectional views showing the proximal hub configuration of one embodiment of the removable balloon delivery system before and after unlocking and retracting the second catheter from the first catheter. 15A-15C are planar views of the proximal hub configuration of one embodiment of a balloon delivery system that is removable before and after unlocking and retracting the second catheter from the first catheter and the second catheter from the third catheter. 1A and 1B are diagrams and sectional views; FIG. 16A-16D are plan and cross-sectional views of one embodiment of a detachable balloon delivery system with an inserted guidewire and comprising a guidewire, three catheters, and three lumens. 17A-17C are partial cross-sectional views illustrating operation of a mechanical latch attachment system with a previously retracted guidewire, according to one embodiment. 18A-18D are partial cross-sectional views illustrating the operation of the mechanical latch attachment system with the guidewire still inserted, according to one embodiment. 19A-19G are plan views illustrating a first sequence of operation of a mechanical latch attachment system according to one embodiment. 20A-20E are cross-sectional detail views illustrating a first sequence of operation of a mechanical latch attachment system according to one embodiment. 21A-21E are cross-sectional detail views illustrating a second sequence of operation of a mechanical latch attachment system according to one embodiment. 22A-22I are plan views illustrating a third sequence of operation of a mechanical latch attachment system according to one embodiment. 23A-23H are cross-sectional detail views illustrating a third sequence of operation of a mechanical latch attachment system according to one embodiment. 24A-24I are plan views illustrating a fourth sequence of operation of a mechanical latch attachment system according to one embodiment. 25A-25I are cross-sectional detail views illustrating a fourth sequence of operation of a mechanical latch attachment system according to one embodiment. 26A-26F are top, perspective, cross-sectional, and detailed views of a male tubular structure of a mechanical latch attachment system according to one embodiment, with defined overall geometric dimensions. 27 is a table listing ranges of geometric dimension values for the male tubular structure embodiment of the mechanical latch attachment system shown in FIG. 26; 28A-28G are plan, perspective, and cross-sectional views of a female tubular structure of a mechanical latch attachment system according to one embodiment, with defined overall geometric dimensions. 29 is a table listing ranges of geometric dimension values for the embodiment of the female tubular structure of the mechanical latch attachment system shown in FIG. 28; 30A-30D illustrate operation of the first embodiment elastomeric tubular structure attachment system in which the elastomeric tubular structure is joined in frictional contact within the proximal neck of the balloon and with the exterior of the first catheter; It is a plane partial sectional view. 31A-31D illustrate the operation of the second embodiment of the elastomeric tubular structure attachment system in which the elastomeric tubular structure is joined in frictional contact with the exterior of the proximal neck of the balloon and the exterior of the first catheter; It is a plane partial sectional view showing. FIGS. 32A-32D illustrate a third embodiment of an elastomeric tubular structure attachment system in which the elastomeric tubular structure is joined in frictional contact with the exterior of the first catheter and the exterior of the proximal neck of the balloon; It is a plane fragmentary sectional view showing operation. 33A-33B are cross-sectional views of the proximal portion of the embodiment of the balloon shown in FIG. 5A illustrating the operation of the attachment system for an elastomeric tubular structure according to the embodiment shown in FIG. 34A-34B are cross-sectional views of the proximal portion of the embodiment of the balloon shown in FIG. 5A illustrating the operation of the attachment system for an elastomeric tubular structure according to the embodiment shown in FIG. 35A-35B are cross-sectional views of the proximal portion of the embodiment of the balloon shown in FIG. 5A illustrating the operation of the attachment system for an elastomeric tubular structure according to the embodiment shown in FIG. 36A-36F are plan views illustrating a first sequence of operation of the attachment system for an elastomeric tubular structure according to the embodiment shown in FIG. 37A-37E are cross-sectional detail views showing a first sequence of operation of the attachment system for an elastomeric tubular structure according to the embodiment shown in FIG. 38A-38J are plan partial cross-sectional views illustrating a second sequence of operation of the attachment system for an elastomeric tubular structure according to the embodiment shown in FIG. 39A-39H are cross-sectional detail views illustrating a second sequence of operation of the attachment system for an elastomeric tubular structure according to the embodiment shown in FIG. 40A-40K are plan views of embodiments of balloons having the shape of the embodiment shown in FIG. 3 incorporating various layer types defined in FIG. 3 in various regions of the balloon. 41A-H are cross-sectional details showing a third sequence of operation of the attachment system for an elastomeric tubular structure according to the embodiment shown in FIG. 42A-C are plan and cross-sectional views of an elastomeric or elastic tubular structure of a friction fit attachment system according to one embodiment with its defined geometric dimensions. 43 is a table listing ranges of geometric dimension values for the elastomeric or resilient tubular structure embodiment of the friction fit mounting system shown in FIG. 44A-B are cross-sectional views illustrating the operation of the valve assembly in the distal nosecone according to one embodiment wherein retraction of the second catheter causes the valve to close and prevent fluid flow through the distal neck of the balloon, according to one embodiment. . 45A-F illustrate a first sequence of operation of a friction fit attachment system comprising an elastomeric or elastic valve and an elastomeric or elastic tubular structure according to the embodiment shown in FIGS. 30 and 44; It is a top view. 46A-E illustrate a first sequence of operation of a friction fit attachment system comprising an elastomeric or elastic valve and an elastomeric or elastic tubular structure according to the embodiment shown in FIGS. 30 and 44; It is a cross-sectional detailed view. 47A-J illustrate a second sequence of operation of a friction fit attachment system comprising an elastomeric or elastic valve and an elastomeric or elastic tubular structure according to the embodiment shown in FIGS. 30 and 44; It is a top view. 48A-I are cross-sections showing a second sequence of operation of a friction fit mounting system comprising an elastomeric or resilient valve and an elastomeric or resilient tubular structure according to the embodiment shown in FIGS. 30 and 44; It is a detailed view. 49A-D are plan, cross-sectional and perspective views of a distal nosecone incorporating a valve assembly according to one embodiment. Figure 50 is a cross-sectional view of the distal valve assembly shown in Figures 49A-D defining its general geometric dimensions. 51 is a table listing ranges of values for the geometric dimensions of the distal valve assembly shown in FIG. 50; FIG. Figures 52A-C are cross-sectional views of an embodiment of a balloon having various components attached to its proximal and distal necks. FIGS. 53A-C illustrate the operation of a first embodiment of an electrolytic separation system in which an electrolytically sensitive tubular structure acting as an anode is joined into both the proximal neck of the balloon and the first catheter; It is a plane partial sectional view showing. FIGS. 54A-C illustrate the operation of a second embodiment of an electrolytic separation system in which an electrolytically sensitive tubular structure acting as an anode is joined to the outside of both the proximal neck of the balloon and the first catheter. It is a plane partial sectional view showing. 55A-E are cross-sectional and detailed cross-sectional views of an electrolytically sensitive tubular structure serving as the anode of an electrolytic separation system according to one embodiment defining its general geometric dimensions. FIG. 56 is a table listing ranges of geometric dimension values for the anode embodiment shown in FIG. 57A-D are plan, cross-sectional, detailed cross-sectional and perspective views of the anode shown in FIG. 58A-E are plan views showing a first sequence of operation of the electrolytic separation system according to the embodiment shown in FIGS. 55 and 57. FIG. 59A-E are cross-sectional details showing a first sequence of operation of the electrolytic separation system according to the embodiment shown in FIGS. 55 and 57. FIG. 60A-I are plan views illustrating a second sequence of operation of the electrolytic separation system according to the embodiment illustrated in FIGS. 55 and 57. FIG. 61A-H are cross-sectional details showing a second sequence of operation of the electrolytic separation system according to the embodiment shown in FIGS. 55 and 57. FIG. 62A-I are plan views illustrating a third sequence of operation of the electrolytic separation system according to the embodiment illustrated in FIGS. 55 and 57. FIG. 63A-I are cross-sectional details showing a third sequence of operation of the electrolytic separation system according to the embodiment shown in FIGS. 55 and 57. FIG. 64A-D are plan partial cross-sectional views illustrating the operation of the first embodiment electrothermal separation system with heat sensitive tubular structures joined into both the proximal neck of the balloon and the first catheter. 65A-D are cross-sectional and detailed cross-sectional views of a heat sensitive tubular structure used in the embodiment of electrothermal separation system shown in FIG. 64 defining its general geometric dimensions. 66 is a table listing ranges of geometric dimension values for the embodiment of the thermally sensitive tubular structure shown in FIG. 67A-D are plan partial cross-sectional views illustrating the operation of a second embodiment of an electrothermal separation system in which the distal end of the first catheter is heat-sensitive. 68A-D are cross-sectional and detailed cross-sectional views of the heat-sensitive distal end of the first catheter used in the embodiment of electrothermal separation system shown in FIG. 67 defined by its general geometric dimensions. is. 69 is a table listing ranges of geometric dimension values for the embodiment of the heat-sensitive distal end of the first catheter shown in FIG. 68; 70A-D are plan partial cross-sectional views illustrating the operation of a third embodiment electrothermal separation system in which a heat sensitive material joins the first catheter to the elastic structure in the proximal balloon neck. 71A-C are cross-sectional and detailed cross-sectional views of a thermal junction used in the embodiment of the electrothermal isolation system shown in FIG. 70 defining its general geometric dimensions. FIG. 72 is a table listing ranges of geometric dimension values for the thermal junctions shown in FIG. 73A-F are plan views showing a first sequence of operation of the electrothermal separation system according to the embodiment shown in FIGS. 64 and 65. FIG. 74A-E are cross-sectional details showing a first sequence of operation of the electrothermal separation system according to the embodiment shown in FIGS. 64 and 65. FIG. 75A-I are plan views showing a second sequence of operation of the electrothermal separation system according to the embodiment shown in FIGS. 64 and 65. FIG. 76A-K are cross-sectional details showing a second sequence of operation of the electrothermal separation system according to the embodiment shown in FIGS. 64 and 65. FIG. 77A-I are plan views showing a third sequence of operation of the electrothermal separation system according to the embodiment shown in FIGS. 64 and 65. FIG. 78A-K are cross-sectional detail views showing a third sequence of operation of the electrothermal separation system according to the embodiment shown in FIGS. 64 and 65. FIG. 79A-B are partial cross-sectional views of balloons with two embodiments of expandable retention structures. 80A-F are plan views showing a first sequence of operation of a detachable balloon catheter incorporating an expandable retention structure secured to the distal neck of the balloon and a mechanical latch attachment system according to one embodiment; be. 81A-I are plan views showing a second sequence of operation of a detachable balloon catheter incorporating an expandable retention structure secured to the distal neck of the balloon and a mechanical latch attachment system according to one embodiment; be. 82A-I are plan views showing a third sequence of operation of a detachable balloon catheter incorporating an expandable retention structure secured to the distal neck of the balloon and a mechanical latch attachment system according to one embodiment; is. 83A-D are plan, cross-sectional and perspective views illustrating a pleating and folding sequence for a balloon according to one embodiment. 84A-B are cross-sectional views showing pleated balloons according to embodiments employing three or five pleats having specific defined geometric dimensions. Figure 85 is a table listing ranges of dimensional values for balloons, balloons including the embodiment shown in Figure 84, and their associated pleat designs. FIG. 86 is a schematic illustration of a second catheter and second medical device functioning as a coil delivery system according to one embodiment having defined overall geometric dimensions. FIG. 87 is a table listing range values for the dimensions of the second catheter and second medical device functioning as the coil delivery system shown in FIG. 86 based on a 0.014″ guidewire platform. FIG. 88 is a table listing ranges of dimensional values for the second catheter and second medical device functioning as the coil delivery system shown in FIG. 86 based on a 0.018″ guidewire platform. FIG. 89 is a table listing ranges of dimensional values for the second catheter and second medical device functioning as the coil delivery system shown in FIG. 86 when based on a 0.035/0.038″ guidewire platform; is. FIG. 90 is a table listing ranges of values for the length dimensions of the second catheter and second medical device functioning as the coil delivery system shown in FIG. 86 for three common guidewire platforms. FIG. 91 is a table listing ranges of values for diameter dimensions of the second catheter and second medical device functioning as the coil delivery system shown in FIG. 86 for three common guidewire platforms. 92A-C are cross-sectional views of a terminal bifurcation aneurysm according to one embodiment with its general geometric dimensions defined. 93A-M are cross-sectional views of a terminal bifurcation aneurysm showing a sequence of treatments using a detachable balloon catheter according to one embodiment. 94A-M are cross-sectional views of a terminal bifurcation aneurysm with a SAC having a smaller daughter aneurysm showing a sequence of treatments using a detachable balloon catheter according to one embodiment. 95A-B are cross-sectional views of a sidewall aneurysm with its defined overall geometry before and after treatment with a detachable balloon catheter according to one embodiment. 96A-B are cross-sectional views of a terminal bifurcation aneurysm with its defined overall geometric dimensions before and after treatment with a detachable balloon catheter according to one embodiment. 97A-B are schematic diagrams showing the direction of converging blood flow and lumen diameter of arteries and veins. Figures 98A-B show an artery using a detachable balloon catheter with an expandable retention structure that is deployed during venous therapy to assist in positioning the vascular coil within the expanded balloon and securing the balloon. 1 is a schematic diagram showing occlusion of a vein and a vein; FIG. 99A-B, pre- and post-treatment with a detachable balloon catheter through the use of an expandable retention structure to ensure assisted placement of a balloon and vascular coil within an expanded balloon, according to one embodiment. Fig. 2 is a cross-sectional view of the left atrial appendage with its general geometric dimensions scaled; 100A-B are partial cross-sectional views of an aortic valve with paravalvular leak before and after treatment with a detachable balloon catheter with assisted placement of a vascular coil within an inflated balloon, according to one embodiment. 101A-F are plan views showing a first sequence of operation of a detachable balloon catheter incorporating an expandable retention structure secured to the proximal neck of the balloon and a mechanical latch attachment system according to one embodiment; be. 102A-J are plan views showing a second sequence of operation of a detachable balloon catheter incorporating an expandable retention structure secured to the proximal neck of the balloon and a mechanical latch attachment system according to one embodiment; be. FIGS. 103A-I are third views of the operation of a detachable balloon catheter incorporating an expandable retention structure secured to the proximal neck of the balloon and a mechanical latch attachment system according to one embodiment of the expandable retention structure. It is a top view which shows a sequence. FIG. 104 includes images of treatment of a canine distal bifurcation aneurysm with a metal balloon and coil according to one embodiment. FIG. 105 includes images of treatment of a canine lateral aneurysm with a metal balloon and coil according to one embodiment. FIG. 106 includes images of treatment of a canine compound bifurcation aneurysm with a metal balloon and coil according to one embodiment. 107A-E contain images of various steps in the treatment of a canine compound bifurcation aneurysm according to one embodiment. FIG. 108 includes images of various steps in the treatment of a canine sidewall aneurysm according to one embodiment. FIG. 109 illustrates the radiation difference between a metal balloon and a platinum coil according to one embodiment. 110A-D contain images of various steps in the treatment of a canine lateral wall aneurysm with a polymer balloon and coil according to one embodiment. FIG. 111 includes images of treatment of an open aneurysm neck segment in a dog with additional coils according to one embodiment. FIG. 112 includes images of treatment of a canine distal bifurcation aneurysm with only a metal balloon according to one embodiment. FIG. 113 includes images of treatment of a canine distal bifurcation aneurysm with coils only, according to one embodiment. FIG. 114 includes images comparing treatment of a canine terminal bifurcation aneurysm with a metal balloon and coil versus coil alone according to one embodiment. 115A-B include images of endothelialization of a canine terminal bifurcation aneurysm neck after placement of a balloon and coil according to one embodiment. FIG. 116 includes images related to immediate effects of canine internal mammary artery treatment according to one embodiment. FIG. 117 includes images depicting one month after treatment of the canine internal mammary artery according to one embodiment. FIG. 118 includes images relating to the efficacy of treating canine carotid artery hemorrhage with a metal balloon according to one embodiment. FIG. 119 includes images related to the efficacy of the Amplatzer Vascular Plug II and treatment of canine carotid artery hemorrhage, according to one embodiment. FIG. 120 includes images associated with advancing a metal balloon over a guidewire into the canine superior mesenteric artery, according to one embodiment. 121A-B include images related to treating a canine axillary artery with a metal balloon according to one embodiment. FIG. 122 includes images related to placement of a coil inside an inflated metal balloon in a canine carotid artery, according to one embodiment. Figures 123A-C include images related to the separation of a metal balloon in the canine internal mammary artery according to one embodiment. FIG. 124 includes comparative images of histopathology one month after implantation of various embodiments of the disclosed medical device in the canine internal mammary artery, according to one embodiment. FIG. 125 includes images associated with advancing a polymer and metal wire balloon over a guidewire into the canine axillary artery, according to one embodiment. FIG. 126 includes images associated with dilating a polymer and metal wire balloon in a canine axillary artery, according to one embodiment. Figures 127A-C include images related to coil placement in an expanded polymer and metal wire balloon, according to one embodiment. 128A-D include images associated with treatment of a canine brachial artery with a polymer-only balloon and one coil, according to one embodiment. FIG. 129 includes images associated with a mechanical latch release mechanism according to one embodiment. detailed description

The present disclosure relates generally to medical devices 1 that can be used alone or in combination to treat human patients. When describing these medical devices, the proximal end generally refers to the end outside the patient and within reach of the physician. Distal end generally refers to the end pushed or advanced into the patient. For the individual components of the medical devices described herein, the same proximal and distal orientations are generally maintained as shown in FIGS. 1A and 3A. With respect to the removable balloon 10 portion of the medical devices described herein, the first axis 706 is along the centerline of the device between the proximal region 110 and the distal region 120 of the removable balloon 10. , with the second axis 708 extending perpendicular to the first axis 706 .

The present disclosure relates to a medical device 1 comprising a removable balloon 10 and a catheter or catheter assembly 5, wherein the removable balloon 10 is adapted for fluid expansion and isolation from the catheter or catheter assembly 5 in vivo. It is configured. After separating the expanded removable balloon 10 from the catheter or catheter assembly 5, the removable balloon 10 is configured to maintain the expanded configuration. These devices are also referred to herein as "detachable balloon catheters" or "first medical devices"1. The term balloon, as used herein, refers to a non-porous balloon comprising a lightweight or thin material that can be inflated or expanded by injection of fluid into the central void 115, as shown in FIGS. 1A and 3A. Refers to a hollow structure with a solid wall 30 . As used herein, a balloon may also be referred to as a "hollow expandable structure" or "expandable hollow structure." Various shapes and sizes of removable balloon 10 are described. A removable balloon 10 having one or more layers including a polymer layer 99 and a metal layer 90 is described as shown in FIGS. 7, 8A-J, and 9A-L and shown in FIGS. It is described with various surface treatments and textures. As shown in FIGS. 79A-B and 98B, balloons having various retention structures 731 and surface textures that reduce the risk of migration of the in vivo removable balloon 10 are described, including: 13A-D, 14A-C, 15A-C, and 16A-D, catheter 5 configured for expansion of removable balloon 10, configured to receive guidewire 40. catheter 5 configured for expandable or elongated body 720 throat delivery, catheter 5 configured for X-ray contrast injection, and retention structure 731 prior to deployment. It includes a catheter 5 configured to:

As shown in FIGS. 17A-C, 18A-D, 26A-H, and 28A-G, various means of attaching the removable balloon 10 to the catheter and catheter assembly 5 are described, which are part friction fit (or friction fit) made with an elastomeric or male annular structure 204 as shown in FIGS. fit) 202; friction fit 202 made with an elastomeric or resilient valve 192 as shown in FIGS. 44A-B, 46A-E, 49A-D, and 50; glue and adhesive; as well as other joining methods. As shown in FIGS. 19A-G, 20A-E, and 21A-E, various means of removing the balloon 10 from the catheter and catheter assembly 5 are described, including separation of the connected parts; 30A-D, FIGS. 31A-D, 32A-D, 36A-F and 37A-E, the catheter or catheter can be removed from the expanded removable balloon 10 by overcoming the friction fit 202. pulling apart the assembly 5; bonding the removable balloon 10 to the catheter or catheter assembly 5 by electrolysis as shown in FIGS. dissolution of a portion of the structure; and detachable balloon 10 from catheter or catheter assembly 5 by heating as shown in FIGS. melting the part of the structure that joins the

Various configurations of detachable balloon 10 and detachable balloon catheter 1 are described, along with associated methods of manufacturing them. In one example, the detachable balloon 10 portion of the detachable balloon catheter 1 is configured in a compressed, deflated, or pleated folded configuration for permanent implantation in a human patient. It is configured. As shown in FIGS. 1A, 3A, and 5A-B, removable balloon 10 generally includes distal region 120, proximal region 110 generally opposite distal region 110, and proximal and distal regions. It comprises an intermediate region 100 transitioning between regions 110 and 120 . A first axis 706 extends along the centerline of the device between proximal region 110 and distal region 120 . A second axis 708 extends perpendicular to the first axis 706 . Wall 30 extends generally continuously from proximal region 110 through intermediate region 100 to distal region 120 substantially continuously. Wall 30 has an exterior surface and an interior surface that defines a central void 115 or interior volume. As shown in FIGS. 30A-D, the removable balloon 10 has an opening in the wall 30 of the proximal region 110 that allows the central void 115 or interior volume of the balloon 10 to enter the first catheter. Allows passage of fluid from 173 into central void 115 or the interior volume of balloon 10 and allows passage of a portion of second catheter 174 into central void 115 or the interior volume of balloon 10 . As shown in FIGS. 37A-E and 44A, the removable balloon 10 has an opening in the wall 30 of the distal region 120 such that a portion of the second catheter 174 extends through the central void 115 of the balloon 10 or Allows exit from internal volume

Various configurations of catheter assemblies are described. As shown in FIGS. 13B-C and 14A-C, the first catheter 173, together with the second catheter 174, define a first lumen 162 of annular cross-section to provide a first lumen 162 from the proximal end of the first catheter 173. It allows fluid passage to the distal end of the catheter and into the central void 115 or interior volume of the removable balloon 10 . First catheter 173 further includes a proximal end connected to first proximal hub 179 and a distal portion operably connected or coupled to an opening in wall 30 of proximal region 110 of balloon 10 . Become. Second catheter 174 defines a second lumen 163 of circular cross-section configured to receive at least one of guidewire 40, elongated or expandable body 720, or coagulation fluid. The second catheter 174 has a proximal end connected with a second proximal hub 178; a proximal portion passing through the proximal hub 179 of the first catheter 173; a proximal opening of the balloon 10, the central void 115, and a distal A distal portion passes through the opening. Passage of fluid through first catheter 173 into central void 115 or the interior volume of balloon 10 can effect expansion of balloon 10 .

The present disclosure also relates to a medical device comprising an elongated or expandable body 720. These devices are also referred to herein as “second medical devices” 700 . As used herein, elongated body 720 is a long, thin, flexible structure that can be pushed or carried through the lumen of a catheter and implanted in a patient. Elongated body 720 occupies space and can form complex shapes, but does not expand during or after deployment. As used herein, the expandable body 720 can be constrained, folded, compressed, or pleated and pushed or carried through the lumen of the catheter in the folded configuration. An elongated, thin, flexible structure that can be obtained and implanted in a patient, at least a portion of the expandable body 720 is capable of expanding in size during or after placement. An elongated expandable body 720 that can be used with a first medical device comprising a removable balloon catheter 1 is described.

In some embodiments, the coagulation fluid is injected as a fluid into the central void 115 of the balloon 10 through the first lumen 162 or the second lumen 163, or into the biological tissue adjacent to the expanded balloon 10. The coagulating fluid comprises an adhesive that can be injected into the biological space 904 and becomes solid or semi-solid after passing through the first lumen 162 or the second lumen 163 . Some examples of solidifying fluids include adhesives such as cyanoacrylates or UV curable adhesives, ethylene vinyl alcohol, Onyx® copolymers, or particles whose viscosity increases with physiological salt. In some embodiments, the solid solidifying agent acts to help the expanded and detached balloon 10 of the removable balloon catheter 1 resist deflation, compression, or compaction. do. In some embodiments, the solid solidifying agent acts to help maintain the position of the expanded, separated balloon 10 of the removable balloon catheter 1 . In some embodiments, solid solidifying agents act to reduce the flow of blood or other biological fluids or suspensions through treated arteries 317 , veins 318 or other biological conduits 900 . In some embodiments, solid solidifying agents act to occupy biological space 904 .

Continuing the post-deployment deployment sequence of the detachable balloon 10, as shown in FIGS. 14A-B and 19D-E, the second catheter 174 can be moved forward or backward while the balloon 10 remains fixed in place. can be moved to As shown in FIGS. 16A-D and 41A-D, after removal of the guidewire 40, all or part of the elongated or expandable body 720 or one or more second medical devices 700 comprising a coagulation fluid is removed. can be placed through lumen 163 of second catheter 174 and into biological space 904 adjacent balloon 10 . The second catheter 174 is then pulled back until the distal tip of the second catheter 174 is located in the central void 115 of the balloon, leaving the first catheter 173 and balloon fixed in place. All or all or a portion of the one or more second medical devices 700 comprising an elongated or expandable body 720, coagulation fluid, or other balloon support material may be attached to a second catheter 174, as shown in FIG. 41E. through the second lumen 163 of the balloon 10 into the central void 115 of the balloon 10 .

As shown in FIGS. 41F-H, all or a portion of the balloon and one or more elongated or expandable bodies 720, coagulation fluid, or other balloon support material remains within the patient, but following elongated or expanded Placement of all or part of one or more second medical devices, possibly comprising body 720, coagulation fluid, or other balloon support material, is separated from the expanded balloon and the first and second catheters 173 are placed. and 174 can be removed from the patient.

In some embodiments, as shown in FIGS. 83A-D and 84A-B, the compressed or folded balloon-expandable body 10 comprises a balloon 10 and portions of the wall 30 of the balloon 10 are joined together. or in a much smaller space than the expanded balloon 10. In some embodiments, the constrained balloon 10 is forced and held to a smaller diameter than the expanded balloon 10 . In some embodiments, the balloon portion 10 of the detachable balloon catheter 1 is pleated, folded, or compressed into a shape that occupies less space or less space than the expanded balloon 10, which is referred to as "delivery." called "possible configurations". In some embodiments, the expandable body portion 720 of the second medical device 700 is also constrained or compressed into a shape that occupies a smaller space or diameter than the expanded expandable body 720, which facilitates delivery. called possible configurations.

With or without the adjunctive use of saccular aneurysm 320, artery 317, vein 318, left atrial appendage 800, paravalvular leak 808, other blood-containing structures, biological conduit 900, or one or more elongated bodies 720. Other biospaces 904 are also described that use balloon catheters that are detachable from the body.

A general approach to treating a saccular aneurysm 320 using a detachable balloon catheter 1 and an elongated or expandable body 720 according to one embodiment is sequentially illustrated in FIGS. 93A-M. A removable balloon catheter 1 is selected along with an appropriately sized balloon 10 based on standard imaging techniques. Guidewire 40 is positioned within aneurysm 320 using standard percutaneous delivery methods. The detachable balloon catheter 1 is advanced over the guidewire 40 and the balloon 10 is positioned, positioned within the aneurysm lumen 322 and expanded. Detachable balloon catheter 1 is then withdrawn to ensure intimate contact between balloon 10 and aneurysm neck 324 . Guidewire 40 is retracted. First and second elongated bodies 720 and 721 are advanced through second catheter 174 such that one or more coils or first elongated body extends through aneurysm lumen 322 distal to inflated balloon 10 . placed within. The first catheter 173 is then separated from the proximal neck 130 of the balloon 10 using a separation system that can have various embodiments. Finally, the first catheter 173 is withdrawn. The expanded and separated balloon 10 and first elongated body 720 are retained within the patient to provide complete and durable embolization of the aneurysm 320 . The general approach described above applies to the treatment of different and more complex shaped saccular aneurysms 320, such as distal bifurcation aneurysms 320 with small daughter aneurysms in the sac, as shown in Figures 94A-M. be able to. By placing one or more coils or first elongated body 720 into void 115 of balloon 10, including the additional step of pulling back the distal tip of second catheter 174 into void 115 of balloon 10, FIG. As shown at L, balloon 10 may be reinforced against external compression. The final configuration of the treated aneurysm 320, including the expanded balloon 10, the first elongated body 720 within the aneurysm lumen 322, and the first elongated body 720 within the void 115 of the balloon 10, is shown in FIG. 95B, and FIG. 96B.
balloon

As shown in FIGS. 1-6, various removable balloon shapes and sizes have been described. In some embodiments, the removable balloon 10 can be characterized by including a proximal region 110, an intermediate region 100, and a distal region 110, the proximal and distal regions 110 and 120 generally facing each other. Each body has a proximal region 110 , an intermediate region 100 and a distal region 120 forming a unitary structure of the removable balloon 10 . For this feature, proximal region 110 , intermediate region 100 , and distal region 120 together form the “main body” of removable balloon 10 excluding proximal and distal necks 130 and 140 . In some embodiments, without the intermediate region 100, the detachable balloon can be characterized as including a proximal region 110 and a distal region 120, the proximal and distal regions 110 and 120 being substantially spaced apart from each other. facing each other. For each of these bodies, proximal region 110 and distal region 120 form a unitary structure of removable balloon 10 . For this characterization, proximal and distal regions 110 and 120 together form the "main body" of removable balloon 10, excluding proximal and distal necks 130 and 140. FIG. Removable balloon 10 may be further defined by a first axis 706 and a second axis transverse to the first axis. In one aspect, first axis 706 extends between proximal neck 130 and distal neck 140 .

In some embodiments, the removable balloon 10 takes a general shape comprising one lobe, excluding proximal and distal necks 130 and 140 or neck assemblies 135 and 142, if any. It is configured. Some detachable balloons, when inflated, are generally spherical, spheroidal, oblate spheroidal, prolate rotatory, except for proximal and distal necks 130 and 140 or neck assemblies 135 and 142, if any. It may be configured to assume the shape of an ellipsoid, ellipsoid, oblate ellipsoid, or prolate ellipsoid. Some removable balloons comprise a proximal region 110, a distal region 120, and an intermediate region 100 when expanded. Other removable balloons comprise a proximal region 110, a distal region 120 without an intermediate region 100 when inflated. In some embodiments, the intermediate region 100 of the removable balloon 10 is generally cylindrical when expanded. In some embodiments, detachable balloon 10, when inflated, assumes a generally rectangular or cylindrical shape, excluding proximal and distal necks 130 and 140 and neck assemblies 135 and 142, if any. configured to

In some embodiments, the removable balloon 10 can be defined and described by a proximal region 110 and a distal region 120, each region being generally hemispherical. A hemisphere is formed by each region and is defined by semi-major and semi-minor axes that may be parallel to the first axis 706 or the second axis 708, depending on the length of each axis. In various embodiments, other embodiments of the hemispheres of proximal region 110 have semi-major and semi-minor axes that differ from the axis of distal region 120 . In other embodiments, the hemispheres of proximal region 110 have the same semi-major and semi-minor axes as the axis of distal region 120 . Similarly, for each distal and proximal region 110, the semi-major and semi-minor axes may be different or identical to each other, so that the corresponding region has the shape of an approximately flat hemisphere, prolate hemisphere, or hemisphere. can have Detachable balloon 10 may also be fabricated in many other configurations having a generally spheroidal or ellipsoidal shape.

The proximal region 110 of some detachable balloons 10, when inflated, has proximal and distal necks 130 and 140, if any, or a neck assembly 135, if any, as shown in FIGS. 3A and 3B. and 142 are nearly round in shape. The proximal region 110 of some detachable balloons 10, when inflated, is hemispherical, oblate hemispherical, prolate hemispherical, excluding proximal and distal necks 130 and 140 or neck assemblies 135 and 142, if any. Form a semi-ellipsoid, oblate semi-ellipsoid, prolate semi-ellipsoid, or paraboloid shape. The proximal region 110 of some detachable balloons 10, except for the proximal and distal regions 130 and 140 or neck assemblies 135 and 142, if any, when inflated, as shown in FIGS. 1A and 5A. , approximately conical.

Distal region 120 of some dilatation/detachment balloons 10 is generally rounded in shape, except for proximal and distal necks 130 and 140 or neck assemblies 135 and 142, if any, as shown in FIG. 3A. The distal region 120 of some detachable balloons 10, when inflated, is hemispherical, flat hemispherical, prolate hemispherical, except for proximal and distal necks 130 and 140 or neck assemblies 135 and 142, if any. shape, semi-ellipsoid, oblate semi-ellipsoid, prolate semi-ellipsoid, or paraboloid. Distal region 120 of detachable balloon 10 is generally conical in shape when inflated, except for proximal and distal necks 130 and 140 or neck assemblies 135 and 142, if any. Distal region 120 of detachable balloon 10 is generally conical in shape, except for proximal and distal necks 130 and 140 or neck assemblies 135 and 142, if any, as shown in FIG. 1A.

For some embodiments, removable balloon 10 has a shape in which, when inflated, intermediate region 100 is generally cylindrical except for proximal and distal regions 130 and 135 and neck assemblies 140 and 142 assemblies, if any. As such, and proximal and distal regions 110 and 120 are configured to form an approximately hemisphere, flattened hemisphere, prolate hemisphere, or paraboloid. In other embodiments, the removable balloon 10 is configured such that when inflated, the intermediate region assumes a generally cylindrical shape with the exception of the proximal and distal necks 110 and 120 and neck assemblies 135 and 142 and Proximal and distal regions 110 and 120 are configured to assume a generally conical shape.

For some removable balloons, the intermediate region 100 is generally cylindrical and the proximal or distal regions 110 and 120 are conical, as shown in FIGS. 1A-B, 2A-D, 5A, and 6A-B. and the proximal or distal regions 110 and 120 have a cone angle (defined by the angle between the balloon wall 30 and the balloon first axis 706) of 20-75 degrees. In one embodiment, the shape of the intermediate region of the removable balloon can be defined by rotation about the first axis 706 of a variable radius arc formed along the first axis 706, and the maximum The radius is equal to either the maximum radius 720 of distal region 120 or the maximum radius 710 of proximal region 110 . For some embodiments, the expanded removable balloon has a total length 709 along the first axis 706 that is less than or equal to the maximum diameter 712 of the expanded removable balloon along the second axis 708. be.

As shown in FIGS. 1A-B, 2A-D, 3A-B, and 4A-C, some removable balloons 10, when inflated, have a configured to have a maximum diameter of 2 to 40 mm when measured partially parallel to the second axis 708 . Some removable balloons 10 measure from 2 to 80 mm when inflated, excluding proximal and distal necks 130 and 140 and neck assemblies 135 and 142, if any, when measured parallel to first axis 706. is configured to have a maximum length of Some detachable balloons, comprising proximal region 110, intermediate region 100, and distal region 120, when inflated, have proximal and distal necks 130 and 140 and neck assemblies 135 and 142, if any. It has a maximum length of 2 to 40 mm of the main body or intermediate region 100 when measured parallel to the first axis 706, excluding the length of . Some removable balloons 10, when inflated, have a maximum length measured parallel to first axis 706, excluding the length of proximal and distal necks 130 and 140 and neck assemblies 135 and 142, if any. It has a maximum diameter measured parallel to the second axis 708 that is greater than its length. Some removable balloons 10, when inflated, have a length of proximal and distal necks 130 and 140 and neck assemblies 135 and 142, if any, when measured parallel to first axis 706. It has a maximum diameter measured parallel to the second axis 708 equal to the maximum length. Some removable balloons 10, when inflated, have a maximum diameter measured parallel to second axis 708, excluding proximal and distal regions 130 and 140 and neck assemblies 135 and 142, if any. has a maximum length measured parallel to the first axis 706 that is greater than. In some embodiments, the expanded detachable balloon 10 has a length from the proximal neck 130 to the distal neck of about 4-30 mm or longer and a maximum diameter 712 of about 4-30 mm or longer. .

In some embodiments, as shown in FIGS. 3A-B, 4A-C, 5B, and 6C-D, the maximum radial lengths for the proximal and distal regions 110 and 120 are equal, so the first When viewed in cross-section along axis 706, the removable balloon has a generally circular cross-section. For some other embodiments, the radial lengths at any similar locations for the proximal and distal regions 110 and 120 are unequal so that the expanded removable balloon 10 has a cross-section along the second axis 708 of does not have a substantially circular cross-section when viewed at

In one aspect, the various configurations of the removable balloon 10 can be configured for the proximal and distal regions 110 and 120, as shown in FIGS. 1A-B, 2A-D, 3A-B, and 4A-C. It can be obtained by varying the maximum length (also called “height”) along the first axis 706 independently. For example, height 713 of proximal region 110 is less than height 714 of distal region 120 in other examples. In other examples, height 713 of proximal region 110 may equal height 714 of distal region 120 . In other examples, height 713 for proximal region 110 may be greater than height for distal region 120 . Although both removable balloons 10 have the same maximum diameter, the difference in height of the proximal and distal regions 110 and 120 of each removable balloon results in a difference in the overall shape of the removable balloon 10 .

In other embodiments, height 713 and height 714 of proximal and distal regions 110 and 120, respectively, can create a wide variety of configurations for removable balloon 10 in the first embodiment. In a first embodiment, the height 713 of the proximal region 110 may be approximately 2 mm and the height 714 of the distal region 120 may be approximately 4 mm. In a second embodiment, the height 713 of the proximal region 110 may be approximately 3 mm and the height 714 of the distal region 120 may be approximately 3 mm. In the third embodiment, height 713 of proximal region 110 may be about 2 mm and height 714 of distal region 120 may be about 3.5 mm. In a fourth embodiment, height 713 of proximal region 110 may be about 3 mm and height 714 of distal region 120 may be about 4 mm. As shown in Figures 3A-B, the removable balloon 10 may have several configurations that may be generally spheroidal or generally spherical.

The removable balloon wall 30 may comprise one or more layers, as shown in FIG. As shown in FIGS. 5A-B and 6A-D, the wall 30 thickness can range between 5 and 400 μm or between 0.0002 and 0.016 μm.

Some removable balloon 10 sizes and shapes may be suitable for treating some conditions and others for treating other conditions. For example, a round or spherical detachable balloon 10 may be suitable for treating saccular aneurysms 320 as shown in FIGS. 93A-M and LAA 800 as shown in FIGS. 99A-B. In contrast, cylindrical detachable balloons can be used to treat arteries 317 as shown in FIG. 98A, veins 318 as shown in FIG. 98B, paravalvular leaks 808 as shown in FIGS. may be suitable for In other clinical applications, the removable balloon is configured to assume an expanded configuration comprising two or more lobes, excluding proximal and distal necks 130 and 140 and neck assemblies 135 and 142, if any. may

In some embodiments, all or part of the removable balloon 10 of the removable balloon catheter 1 is non-compliant. In some embodiments, all or part of the removable balloon 10 of the removable balloon catheter 1 is semi-compliant. In some embodiments, all or part of the removable balloon 10 of the removable balloon catheter 1 is compliant. In some embodiments, all or part of the detachable balloon 10 of the detachable balloon catheter 1 is <2%, <4%, <6% when inflated to pressures of 1-20 atmospheres. , <8%, <10%, or >10%.

In some embodiments, removable balloon 10 comprises openings in proximal region 110 to allow passage of fluid from catheter or catheter assembly 5 into removable balloon 10 . In some embodiments, the proximal opening in removable balloon 10 extends away from removable balloon 10, as shown in FIGS. 1A-B, 3A-B, and 5A-B, or or comprising a proximal neck 130 extending into the central void 115 of the removable balloon 10;

As shown in FIGS. 11A-D, one or more annular structures, tubular structures, telescopic structures, catheter segments, or telescopic catheter segments may be joined to the proximal neck 130 of the removable balloon 10. . Such a structure is called a “proximal telescope” 190 and forms proximal neck assembly 135 with proximal neck 130 .

Various configurations of proximal telescope 190 may be employed to achieve various embodiments of proximal neck assembly 135 . The proximal telescope 190 may be shorter, longer, or the same length as the proximal neck 130 of the removable balloon 10 . The proximal telescope 190 may project distally, proximally, both distally and proximally of the proximal neck, or may not project distally or proximally. The outer surface of proximal telescope 190 may be joined to the inner surface of proximal neck 130 . The inner surface of proximal telescope 190 may be joined to the outer surface of proximal neck 130 . Proximal telescope 190 may be joined to proximal neck 130 with an adhesive or glue. Proximal telescope 190 may be rigid, may comprise metal, or may comprise radiopaque metal that is visible under fluoroscopy. Metal proximal telescope 190 may comprise platinum, iridium, gold, silver, stainless steel, nitinol, titanium, or alloys or combinations thereof. Proximal telescope 190 may be flexible and may comprise a polymer. Polymer proximal telescope 190 may comprise Pebax, Nylon, Polyimide, PTFE, or combinations thereof. The polymer proximal telescope 190 is made of polymer or , 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64 , 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, or 80D Shore durometer hardness. The inner layer of the wall of polymer proximal telescope 190 may comprise lubricious polymers including, but not limited to, PTFE, polyimide, composites, or mixtures of polyimide and PTFE. The wall of the polymeric proximal telescope 190 may comprise an intermediate layer located between the outer and inner layers, such intermediate layer comprising metal wires comprising nitinol or stainless steel. and metal wires, including spiral, coiled, braided, woven or linear patterns. An intermediate layer may be included positioned between the outer layer and the inner layer. Proximal telescope 190 may include a lubricious coating on its inner surface, outer surface, or inner and outer surfaces. Proximal telescope 190 may comprise a hydrophilic coating, such as a SurModics Serene coating.

Proximal telescope 190 may comprise a marker band 612 that is clearly visible under fluoroscopy. Marker band 612 may comprise platinum, iridium, gold, silver, or alloys thereof or combinations thereof. Marker band 612 may be joined to the distal end of proximal telescope 190, the proximal end, or both the proximal and distal ends.

Various dimensions of proximal telescope 190 may be specified to achieve various embodiments of proximal neck assembly 135 . The inner diameter or lumen diameter of proximal telescope 190 may be between 0.024 and 0.108 inches. The outer or overall diameter of proximal telescope 190 may be 0.026 to 0.110 inches. The proximal telescope 190 may have a length of 0.3 to 30 mm either before or after separation of the removable balloon 10 from the first catheter 173 when measured parallel to the first axis 706. good. The outer diameter of proximal neck 130 or proximal neck assembly 135 of removable balloon 10 may be 0.042 to 0.108 inches when measured parallel to second axis 708 .

The proximal neck assembly 135 of the detachable balloon 10 may further comprise a proximal nosecone, which allows the walls of the saccular aneurysm 320, the artery 317, to sag when the detachable balloon catheter 1 is advanced or retracted. , vein 318 , LAA 800 , other blood-containing structures, biological conduit 900 , or biological space 904 . Although not shown, the proximal nosecone 198 is structurally and functionally similar to the distal nosecone shown in FIGS. 44A-B and 52A-B. The proximal nosecone 198 may have a tapered proximal end, a tapered distal end, or tapered proximal and distal ends. In other embodiments, proximal nosecone 198 comprises one piece, while in other embodiments, proximal nosecone 198 comprises two or more pieces joined together, including those joined with glue or adhesive. may comprise In some embodiments, the proximal nosecone 198 is made of polyetheretherketone (PEEK), polycarbonate, nylon, polyimide, Pebax, PTFE, silicone, polyurethane, copolyester polymer, thermoplastic rubber, silicone-polycarbonate copolymer, polyethylene. It comprises one or more polymers including ethyl-vinyl-acetate (PEVA) copolymers, biocompatible elastomers, biocompatible elastic materials, or biocompatible adhesives. In some embodiments, the proximal nosecone 198 has a length of 1-10 mm. In some embodiments, the proximal nosecone 198 has an outer diameter of 0.058-0.18 inches. In some embodiments, proximal nosecone 198 is joined to proximal neck 130 . In some embodiments, the proximal nosecone is joined to a portion of proximal neck assembly 190 that includes proximal telescope 190 . In some embodiments, proximal nosecone 198 joins both proximal neck 130 and a portion of proximal neck assembly 135 . In some embodiments, the proximal nosecone 198 joins a portion of the outer surface of the proximal balloon neck 130 or a portion of the proximal neck assembly 135 . In some embodiments, at least a portion of proximal neck 130 comprises a layer of radiopaque metal that is visible under fluoroscopy.

In some embodiments, the removable balloon comprises an opening in the distal region 120 to allow a portion of the catheter or catheter assembly 5 to pass into and through the central void 115 of the removable balloon 10. and optionally extend distally of the removable balloon, thereby allowing the guidewire 40 and/or second catheter 174 to pass completely through the removable balloon 10. do. In some embodiments, the distal opening in the removable balloon 10 extends away from the removable balloon 10, as shown in FIGS. 1A-B and 3A-B, or It comprises a distal neck 140 extending into the central cavity 115 of 10 .

One or more annular structures, tubular structures, telescopic structures, catheter segments or telescopic catheter segments are joined to the distal neck 140 of the removable balloon 10, as shown in FIGS. 11E-H and 52C. good too. Such a structure is referred to as a “distal telescope” 185 and together with distal neck 140 form distal neck assembly 142 .

Various configurations of distal telescope 185 may be employed to achieve various embodiments of distal neck assembly 142 . Distal telescope 185 may be longer, shorter, or the same as distal neck 140 of removable balloon 10 . Distal telescope 185 may project proximally, distally, both distally and proximally, or neither distally nor proximally of distal neck 140 . The outer surface of distal telescope 185 of distal neck 140 may be joined to the inner surface of distal neck 140 . The inner surface of distal telescope 185 may connect to the outer surface of distal neck 140 . Distal telescope 185 may be joined to distal neck 140 with an adhesive or glue. Distal telescope 185 may be rigid, may comprise metal, or may comprise radiopaque metal that is visible in fluorescence transmission. Metal distal telescope 185 may comprise platinum, iridium, gold, silver, stainless steel, nitinol, titanium, or alloys or combinations thereof. Distal telescope 185 may be flexible and may comprise a polymer. Polymer distal telescope 185 may comprise Pebax, nylon, polyimide, PTFE, or combinations thereof. The polymer distal telescope 185 is made of polymer or , 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64 , 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, or 80D Shore durometer hardness. The inner layer of the wall of polymer distal telescope 185 may comprise lubricious polymers including PTFE, polyimide, composites, or mixtures of polyimide and PTFE. The wall of the polymer distal telescope 185 may include intermediate layers located between the outer and inner layers, such intermediate layers including metal wires including nitinol or stainless steel and spiral, coil , including metal wires arranged in knitted, woven, or linear patterns. Distal telescope 185 may comprise a lubricious coating on its inner surface, outer surface, or both inner and outer cotton. Distal telescope 185 may comprise a hydrophilic coating, such as a Serene coating from SurModics.

Distal telescope 185 may comprise a marker band 612 that is clearly visible under fluoroscopy. Marker band 612 may be free of platinum, iridium, gold, silver, or alloys or combinations thereof. Marker band 612 may be joined to distal end, proximal end, or both proximal and distal ends of distal telescope 185 .

Various dimensions of distal telescope 185 may be specified to achieve various embodiments of distal neck assembly 142 . The inner diameter or lumen diameter of distal telescope 185 may be between 0.024 and 0.108 inches. The outer or overall diameter of distal telescope 185 may be 0.026 to 0.110 inches. Distal telescope 185 has a length of 0.3 to 30 mm measured parallel to first axis 706 either before or after separation of detachable balloon 10 from first catheter 173. good too. The inner diameter of distal neck 140 or distal neck assembly 142 may be 0.024 to 0.068 inches measured parallel to second axis 708 . The outer diameter of distal neck 140 or distal neck assembly 142 may be 0.030 to 0.096 inches measured parallel to second axis 708 .

In some embodiments of the detachable balloon catheter 1, the outer diameter of the distal telescope 185 is greater than the inner diameter of the proximal telescope 190, so that the proximal portion of the distal telescope 185 is located at the first Lumen 162 cannot be entered. In some embodiments, the outer diameter of the distal telescope 185 of the detachable balloon catheter 1 is greater than the inner diameter of the proximal neck 130, so that the proximal portion of the distal telescope 185 is located within the first lumen. 162 cannot be entered. In some embodiments of the detachable balloon catheter 1, the outer diameter of the distal telescope 185 is greater than the inner diameter of the first catheter 173 so that the proximal portion of the distal telescope 185 is located within the first lumen 162. cannot enter.

As shown in FIGS. 44A-B and 52A-B, the distal neck assembly 142 of the removable balloon 10 further comprises a distal nosecone 191 to provide a The risk of damage to the walls of saccular aneurysm 320, artery 317, vein 318, LAA 800, other blood-containing structures, biological conduit 900 or biological space 904 is reduced. The distal nosecone 191 may have a tapered proximal end, a tapered distal end, or tapered proximal and distal ends. In some embodiments, the distal nosecone 191 may comprise one piece, while in other embodiments the distal nosecone 191 may be glued or glued together, as shown in Figures 49A-D. comprising two or more pieces joined together, including those joined together with In some embodiments, distal nosecone 191 is made of polyetheretherketone (PEEK), polycarbonate, nylon, polyimide, Pebax, PTFE, silicone, polyurethane, copolyester polymer, thermoplastic rubber, silicone-polycarbonate copolymer, polyethylene. It comprises one or more polymers including ethyl-vinyl-acetate (PEVA) copolymers, biocompatible elastomers, biocompatible elastic materials, or biocompatible adhesives. In some embodiments, the distal nosecone 191 has a length of 1-10 mm. In some embodiments, distal nosecone 191 has an outer diameter of 0.058 to 0.18 inches. In some embodiments, distal nosecone 191 joins distal neck 140 . In some embodiments, distal nosecone 191 is joined to a portion of distal neck assembly 142 that includes distal telescope 185 . In some embodiments, distal nosecone 191 is joined to both distal neck 140 and a portion of distal neck assembly 142 . In some embodiments, a portion of the inner surface of distal nosecone 191 joins a portion of the outer surface of distal balloon neck 140 or a portion of distal neck assembly 142 . In some embodiments, at least a portion of distal neck 140 comprises a layer of radiopaque metal that is visible under fluoroscopy.

The removable balloon 10 may be a polymeric balloon 12, as shown in Figures 7.7, 8B and 9B, and any proximal and distal openings within the removable balloon 10 comprising a continuous layer of Polymer 99, except for The continuous polymer layer 99 of the removable polymer balloon 12 may comprise PET, Nylon, or Pebax. The thickness of the polymer layer 99 of the removable polymer balloon 12 may range between 5 and 300 microns or between 0.0002 and 0.012 inches. The removable polymeric balloon 12 comprises an additional layer of non-metallic coating or polymer 97, which may be continuous or discontinuous, as shown in Figures 7.5, 8B, and 9B. may be internal to the continuous polymer layer 99 or external to the continuous polymer layer 99 which may be continuous or discontinuous. Additional layers of non-metallic coatings or polymers 97 may comprise polyurethane, silicone, or poly(p-xylylene) (Parylene). The non-metallic coating of the removable polymer balloon 12 or the additional layer of polymer 97 may have a thickness of 0.1-100 μm. The overall thickness of wall 30 of removable polymer balloon 12 may range between 5 and 300 μm, or between 0.0002 and 0.012 inches. Detachable polymer balloon 12 may not have sufficient strength to maintain an expanded or partially expanded configuration in vivo after separation from catheter or catheter assembly 5 . If no solid or semi-solid material not derived from the patient is present in the central cavity 115 of the expanded removable balloon after separation from the first and second catheters 173 and 174, the removable polymeric balloon 12 may be a catheter or catheter. It may not have sufficient strength to maintain an expanded or partially expanded configuration in vivo after separation from assembly 5 . If the removable polymeric balloon 12 is implanted in an unsealed configuration, the removable polymeric balloon 12 assumes an expanded or partially expanded configuration in vivo after separation from the catheter or catheter assembly 5 . It may not be strong enough to hold. If the pressure within the central cavity 115 or in the interior volume of the expanded removable polymeric balloon 12 is no greater than the pressure outside the expanded removable polymeric balloon 12, the removable polymeric balloon 12 will remain in the catheter or catheter assembly. After separation from 5, it may not have sufficient strength to maintain an expanded or partially expanded configuration in vivo. Molding and balloon blowing techniques can be used to create removable polymeric balloons 12 that closely match the size and shape of various vascular structures, biological conduits 900, or biological spaces, such as saccular arteries. Including, but not limited to, an aneurysm 320, a segment of an artery 317, a segment of a vein 318, an LAA 800, a segment of a paravalvular leak pathway 808, a segment of a biological conduit 900, or a specific biological space.

In some embodiments, all or part of the removable polymer balloon 12 of the removable balloon catheter 1 is non-compliant. In some embodiments, all or all or part of the removable polymer balloon 12 of the removable balloon catheter 1 is semi-compliant. In some embodiments, all or part of the removable polymer balloon 12 of the removable balloon catheter 1 is compliant. In some embodiments, all or a portion of the removable polymer balloon 12 of the removable balloon catheter 1 is <2%, <4%, <6% when inflated to pressures in the range of 1-20 atmospheres. %, <8%, <10%, or >10%.

In some embodiments, the outer surface of the polymeric detachable balloon 12 of the detachable balloon catheter 1 comprises surface structures, as shown in FIGS. 10B-D. In some embodiments, the outer surface of the polymeric detachable balloon 12 of the detachable balloon catheter 1 comprises surface structures having a height of 0.01-1 μm. In some embodiments, the outer surface of the proximal region 110 of the polymeric detachable balloon 12 of the detachable balloon catheter 1 comprises surface structures or surface structures having a height of 0.01-1 μm, FIG. 10A. , intermediate region 100 and distal region 120 are smooth or smoother than proximal region 110 . In some embodiments, the outer surface of the proximal region 110 of the polymer detachable balloon 12 of the detachable balloon catheter 1 configured for implantation into a saccular aneurysm 320 or LAA 800 is a surface structure or O.D. The intermediate region 100 and the distal region 120 are smooth or smoother than the proximal region 110, although comprising surface structures having a height of 01-1 μm.

The removable balloon 10 may be a metallized polymer balloon 14, as shown in Figures 7.2, 8C, 8E, 9C, and 9E, any proximal opening in the removable balloon. It comprises a continuous layer of polymer 99 and a metal layer 90 which may be continuous or discontinuous, except for the portion and distal opening. The continuous polymer layer 99 of the removable metallized polymer balloon 14 may comprise PET, Nylon, or Pebax with a range of between 5-300 μm, or between 0.0002-0.012 inches. There may be. The continuous polymer layer 99 may be an outer layer. Metal layer 90 may comprise gold, titanium, platinum, or combinations or alloys thereof. Metal layer 90 also comprises silver, vanadium, aluminum, nickel, tantalum, zirconium, chromium, silicone, magnesium, niobium, scandium, cobalt, palladium, manganese, molybdenum, alloys thereof, and combinations thereof. good too. Other biocompatible rigid materials or combinations of materials can be used.

Metal layer 90 may have a thickness ranging between 0.1 and 100 μm. Metal layer 90 may be an outer layer. The removable metallized polymeric balloon 14 may be coated with a non-metallic coating, polymer or adhesive 97, as shown in FIGS. 7.3, 7.4, 7.6, 8C-J, and 9C-J. may comprise additional layers, which may be continuous or discontinuous, may be internal to the continuous polymer layer 99, or external to the continuous polymer layer 99; It may be inside the metal layer 90 or outside the metal layer 90 . Additional layers of non-metallic coatings, polymers, or adhesives may comprise polyurethane, silicone, or Parylene. An additional layer 97 of non-metallic coating, polymer or adhesive 97 may have a thickness of 0.1-100 μm. Additional layers 97 of non-metallic coatings, polymers, or adhesives may be outer layers, inner layers, or both outer and inner layers. The overall thickness of wall 30 of removable metallized polymer balloon 14 may range between 5-300 μm, or between 0.0002-0.012 inches. At least a portion of the outer surface of the removable metallized polymer balloon 14 may comprise a rounded, pebbled, or granular surface structure, such as pebbles or granules, as shown in Figures 10B-D. has a surface height of 0.01-10 μm. At least a portion of the outer surface of the removable metallized polymer balloon 14 may comprise a metal having a round, pebbled, or granular surface structure, the pebbles or granules having a surface area of 0.01-10 μm. have height. At least a portion of wall 30 of removable metallized polymer balloon 14 may be formed by electroplating or electroforming. Electroplated or electroformed metal is applied over at least a portion of the intermediate region 100 of the removable metallized polymer balloon 14 and over at least a portion of the proximal region 110 of the removable metallized polymer balloon 14. , over at least a portion of the proximal region 110 and the intermediate region 100 , over at least a portion of the distal region 120 and the intermediate region 100 of the removable metallized polymer balloon 14 , near the removable metallized polymer balloon 14 . It may overlie at least a portion of distal region 110 , intermediate region 100 , and distal region 120 . In some embodiments, a fully metallized or fully plated removable metallized polymer balloon 14 is provided by plating the entire outer layer of the continuous polymer removable balloon 12 inner or base layer 99. Various sizes and shapes of fully metallized or fully plated removable metallized polymer balloons 14 can be made. In some embodiments, the partially metallized or partially plated removable polymer balloon 20 is plated on the inner layer of the continuous polymer removable balloon 12 or part of the outer layer of the base layer 99. A variety of sizes and shapes of partially metallized or partially plated removable metallized polymer balloons 20 can be made.

The metal portion 90 of the removable metallized polymer balloon 14 may be formed as a wire and configured in a spiral, coil, braid, weave, or straight, as shown in Figures 9I-L. The metal wire may be bonded to the adjacent polymer layer 99 by glue or adhesive 95 . A metal wire is placed over at least a portion of the intermediate region 100 of the removable metallized polymer balloon 14 and over at least a portion of the proximal region 110 of the removable metallized polymer balloon 14 . of the removable metallized polymer balloon 14 over at least a portion of the distal region 120 of the removable metallized polymer balloon 14 and over at least a portion of the proximal region 110 and intermediate region 100 of the removable metallized polymer balloon 14 . Can be present over at least a portion of the distal region 120 and the intermediate region 100 and over at least a portion of the proximal region 110 , the intermediate region 110 , and the distal region 120 of the detachable metallized polymeric balloon 14 . . The cross-sectional shape of the metal wire can be circular, oval, square, or rectangular. The metal wire 10 can have a diameter or width of 10-1000 μm. The removable metallized polymer balloon 14 may range between 5 and 1500 microns or between 0.0002 and 0.060 inches.

In one example, as shown in FIG. 7.3, the metal portion 90 of the removable metallized polymer balloon 14 is formed as a wire and bonded to the outer surface of a continuous polymer layer 99 by glue or adhesive 95. . In another example, the metal portion 90 of the removable metallized polymer balloon 14 is formed as a wire and bonded to the outer surface of a continuous polymer layer 99 by glue or adhesive 95, including a coating and adhesive 97. A non-metallic layer or layers is applied to the outer surface of the removable polymeric balloon 12 with metal wires, as shown in FIG. 7.6, and the coating and adhesive 97 comprises polyurethane, silicone, or parylene. Become.

The removable metallized polymer balloon 14 may have sufficient strength to maintain an expanded or partially expanded configuration in vivo after separation from the catheter or catheter assembly 14 . If no solid or semi-solid material not derived from the patient is present in the central void 115 of the removable expanded metal balloon 16 after separation from the first and second catheters 173 and 174, the removable metallized polymer balloon 14 will: It may have sufficient strength to maintain an expanded or partially expanded configuration in vivo after separation from the catheter or catheter assembly 14 . If the removable metallized polymer balloon 14 is implanted in an unsealed configuration, the removable metallized polymer balloon 14 may be in an expanded or partially expanded configuration after separation from the catheter or catheter assembly 14. may have sufficient strength to maintain in vivo. If the pressure in the central void 115 or interior volume of the expanded removable metallized polymer balloon 14 is greater than the pressure outside the expanded removable metallized polymer balloon 14, the removable metallized polymer balloon 14 may be removed from the catheter. Or it may have sufficient strength to maintain an expanded or partially expanded configuration in vivo after separation from the catheter assembly 14 .

Detachable metallized polymer balloon 14 may not have sufficient strength to maintain an expanded or partially expanded configuration after separation from catheter or catheter assembly 5 . If no solid or semi-solid material not derived from the patient is present within the central void 115 of the expanded removable metallized polymer balloon 14 after separation from the first and second catheters 173 and 174, the removable metallized polymer Balloon 14 may not have sufficient strength to maintain an expanded or partially expanded configuration after separation from catheter or catheter assembly 5 . When the removable metallized polymer balloon 14 is implanted in an unsealed configuration, the removable metallized polymer balloon 14 is in an expanded or partially expanded configuration after separation from the catheter or catheter assembly 5. may not be strong enough to maintain If the pressure in the central void 115 or interior volume of the expanded removable metallized polymer balloon 14 is greater than the pressure outside the expanded removable metallized polymer balloon 14, the removable metallized polymer balloon 14 may be removed from the catheter. or may not have sufficient strength to maintain an expanded or partially expanded configuration after separation from catheter assembly 5 .

Various vascular structures, biological conduits 900 or biological spaces can be fabricated by applying a layer of metal 90 by using mold and balloon blowing techniques and then electroplating, electroforming, or bonding metal wires. A detachable metallized polymer balloon 14 that closely matches size and shape can be made to provide saccular aneurysms 320, segments of arteries 317, segments of veins 318, LAA 800, paravalvular leak pathways 808, biological conduits 900, Or a specific biological space, including but not limited to.

According to various embodiments of the partially or fully metallized detachable balloon 14, the metal layer 90 is shown in FIGS. 6. As shown in FIGS. 8A, 8C-J, 9A, and 9C-L, if desired, only the wall 30 of the removable balloon 10 extends to the majority of the removable metallized polymer balloon 14. may be present in a proportion of By way of example and not limitation, the metal layer 90 may cover 100% of the main body or intermediate region 100 of the removable metallized polymer balloon 14, or less than 100% of the main body or intermediate region 100. Similarly, metal layer 90 may cover 100% of proximal region 110 of removable metallized polymer balloon 14 or less than 100% of proximal region 110 . Similarly, the metal layer 90 may cover 100% of the distal region 120 of the removable metallized polymer balloon 14, or less than 120% of the distal region. Metal layer 90 may cover 1-99% of removable metallized polymer balloon 14 .

In some embodiments, all or part of the removable metallized polymer balloon 14 of the removable balloon catheter 1 is non-compliant. In some embodiments, all or part of the removable metallized polymer balloon 14 of the removable balloon catheter 1 is semi-compliant. In some embodiments, all or part of the removable metallized polymer balloon 14 of the removable balloon catheter 1 is compliant. In some embodiments, all or part of the removable metallized polymer balloon 14 of the removable balloon catheter 1 is <2%, <4%, <6% when inflated at pressures <20 atmospheres. %, <8%, <10%, or >10%.

In some embodiments, as shown in FIGS. 10B-D, the outer surface of the metallized polymer detachable balloon 14 of the detachable balloon catheter 1 comprises a surface structure. In some embodiments, the outer surface of the metallized polymer detachable balloon 14 of the detachable balloon catheter 1 comprises surface structures having a height of 0.01-1 μm. In some embodiments, the outer surface of the proximal region 110 of the metallized polymer detachable balloon 14 of the detachable balloon catheter 1 comprises surface structures or surface structures having a height of 0.01-1 μm. However, intermediate region 100 and distal region 120 are smooth or smoother than proximal region 110 . In some embodiments, the outer surface of the proximal region 110 of the metallized polymer detachable balloon 14 of the detachable balloon catheter 1 configured for implantation into a saccular aneurysm 320 or LAA 800 has a surface structure or 0 The intermediate region 100 and the distal region 120 are smooth or smoother than the proximal region 110, as shown in FIG.

In some embodiments, the outer surface of the metallized polymer detachable balloon 14 of the detachable balloon catheter 1 comprises a layer of titanium that is 5-500 Angstroms thick. In some embodiments, the outer surface of the metallized polymer detachable balloon 14 of the detachable balloon catheter 1 comprises a gold layer that is 100-10,000 ounces thick. In some embodiments, the outer layer of the metallized polymer detachable balloon 14 of the detachable balloon catheter 1 is 0.1-3 μm thick, or 0.1, 0.2, 0.3, 0.4, 0.4 μm thick. .5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7 , 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, or It comprises a gold layer that is 3.0 μm. In some embodiments, the outer surface of the metallized polymer detachable balloon 14 of the detachable balloon catheter 1 comprises a gold layer that is 0.1-3 μm thick and is made by sputtering, vacuum deposition. It comprises an inner layer and an outer layer made by electroplating or electroforming. In some embodiments, the outside of the metallized polymer detachable balloon 14 of the detachable balloon catheter 1 comprises a gold layer that is 0.1-3 μm thick and is made by sputtering or vacuum deposition. It comprises an inner layer comprising titanium and a gold layer made by electroplating or electroforming.

In some embodiments, the outer layer of the metallized polymer removable balloon 14 of the removable balloon catheter 1 configured for implantation into a saccular aneurysm 320 or LAA 800 is 5-500 Angstroms thick titanium. comprising a layer. In some embodiments, the outer surface of the metallized polymer detachable balloon 14 of the detachable balloon catheter 1 configured for implantation into a saccular aneurysm 320 or LAA 800 is between 100 and 10,000 oz. It comprises a gold layer that is thick.

As shown in Figures 7.1, 8A and 9A, the removable balloon 10 comprises a continuous layer of metal 90, except for any proximal and distal openings. It may be a metal balloon 16 that is not a material. The continuous metal layer 90 of the removable metal balloon 16 may comprise gold, platinum, or combinations or alloys thereof. The overall thickness of wall 30 of removable metal balloon 16 may range between 5 and 300 μm, or between 0.0002 and 0.012 inches. A portion of the outer surface of the removable metal balloon 16 may comprise a rounded, pebbled, or granular surface structure, as shown in FIGS. It has a surface height of 10 μm. At least a portion of wall 30 of removable metal balloon 16 may be formed by electroplating or electroforming. At least a portion of wall 30 of removable metal balloon 16 may be annealed. In some embodiments, metal balloon 16 can be referred to as an expandable metal structure, a hollow metal structure, or a hollow, expandable metal structure.

The removable metal balloon 16 may have sufficient strength in vivo to maintain an expanded or partially expanded shape after separation from the catheter or catheter assembly 16 . If no solid or semi-solid material not derived from the patient is present within the central void 115 of the expanded removable metal balloon 16 after separation from the first and second catheters 173 and 174, the removable metal balloon 16: It may have sufficient strength to maintain an expanded or partially expanded shape in vivo after separation from the catheter or catheter assembly 16 . When the removable metal balloon 16 is implanted in an unsealed configuration, the removable metal balloon 16 assumes an expanded or partially expanded shape in vivo after separation from the catheter or catheter assembly 16. It may have sufficient strength to maintain. When the pressure in the central void 115 or interior volume of the expanded removable metal balloon 16 is no greater than the pressure outside the expanded removable metal balloon 16, the removable metal balloon 16 is no longer a catheter or catheter assembly. It may have sufficient strength to maintain an expanded or partially expanded shape in vivo after separation from 16 .

The removable metal balloon 16 may not have sufficient strength in vivo to maintain its expanded or partially expanded shape after separation from the catheter or catheter assembly 16 . If no solid or semi-solid material not derived from the patient is present within the central void 115 of the expanded removable metal balloon 16 after separation from the first and second catheters 173 and 174, the removable metal balloon 16: It may not have sufficient strength to maintain its expanded or partially expanded shape in vivo after separation from the catheter or catheter assembly 16 . When the removable metal balloon 16 is implanted in an unsealed configuration, the removable metal balloon 16 maintains an expanded or partially expanded shape in vivo after separation from the catheter or catheter assembly 16. may not be strong enough to If the pressure in the central void 115 or interior volume of the expanded removable metal balloon 16 is not greater than the pressure outside the expanded removable metal balloon 16, the removable metal balloon 16 will be ejected from the catheter or catheter assembly 16. It may not have sufficient strength to maintain its expanded or partially expanded shape in vivo after separation.

By fabricating conductive mandrels 740 of various sizes and shapes and then applying a metal layer 90 by electroplating or electroforming, the size and shape of various defect structures, biological conduits 900, or biological spaces can be precisely matched. A detachable metal balloon 16 conforming to the saccular aneurysm 320, a segment of an artery 317, a segment of a vein 318, an LAA 800, a paravalvular leak pathway 808, a biological conduit 900 or a specific biological space. Including but not limited to segments.

In some embodiments, the removable metal balloon 16 portion of the removable balloon catheter 1 is non-compliant. In some embodiments, all or part of the removable metal balloon 16 of the removable balloon catheter 1 expands <2% during expansion.

In some embodiments, the outer surface of the removable metal balloon 16 of the removable balloon catheter 1 comprises a surface structure. In some embodiments, the outer surface of the metal detachable balloon 16 of the detachable balloon catheter 1 comprises surface structures having a height of 0.01-1 μm. In some embodiments, the outer surface of the proximal region 110 of the metal balloon 16 of the detachable balloon catheter 1 comprises surface structures or surface structures having a height of 0.01-1 μm, but the intermediate region and distal region 120 are smooth or smoother than proximal region 110 . In some embodiments, the outer surface of the proximal region 110 of the metal balloon 16 of a detachable balloon catheter 1 configured for implantation into a saccular aneurysm 320 or LAA 800 is a surface structure or 0.01-1 μm , but intermediate region 100 and distal region 120 are smooth or smoother than proximal region 110 .

The removable balloon 10 may be a polymer-coated metal balloon 18 and includes a continuous layer of metal 90, except for any proximal and distal openings in the removable polymer-coated metal balloon 18. Become. Removable polymer-coated metal balloon 18 may comprise gold, platinum, or combinations or alloys thereof. The removable polymer-coated metal balloon 18 may comprise additional layers of non-metallic coatings or polymers 97, and may be continuous or discontinuous, outside of the continuous metal layer 90, continuous. It may be within a continuous metal layer 90 or both within and outside a continuous metal layer 90 . Additional layers of non-metallic coatings or polymers 97 may comprise polyurethane, silicone, or Parylene. Additional layers of non-metallic coatings, polymers or adhesives 97 may be continuous or discontinuous, outside the continuous metal layer 90, inside the continuous metal layer, or may be both internal and external to the Additional layers of non-metallic coatings or polymers 97 may comprise polyurethane, silicone, or Parylene. An additional layer of non-metallic coating, polymer, or adhesive 97 may comprise a material that isolates the metal layer 90 from passing electrical current to the inner or outer surface of the removable polymer-coated metal balloon 18 . The additional layer of non-metallic coating or polymer 97 of the removable polymer-coated metal balloon 18 may have a thickness of 0.1-100 μm. The overall thickness of wall 30 of polymer-coated metal balloon 18 may range between 5 and 300 μm, or between 0.0002 and 0.012 inches. At least a portion of wall 30 of polymer-coated metal balloon 18 may be formed by electroplating or electroforming. The removable polymer-coated metal balloon 18 may be annealed.

Detachable polymer-coated metal balloon 18 may have sufficient strength to maintain an expanded or partially expanded configuration in vivo after separation from catheter or catheter assembly 5 . If no solid or semi-solid material not derived from the patient is present in the central void 115 of the expanded removable polymer-coated metal balloon 18 after separation from the first and second catheters 173 and 174, the removable polymer-coated metal balloon 18 is removed. may have sufficient strength to maintain an expanded or partially expanded configuration in vivo after separation from the catheter or catheter assembly 5 . When the removable polymer-coated metal balloon 18 is implanted in an unsealed configuration, the detachable polymer-coated metal balloon 18 is in an expanded or partially expanded configuration after separation from the catheter or catheter assembly 5. may have sufficient strength to maintain in vivo. When the pressure in the central void 115 or interior volume of the expanded removable polymer-coated metal balloon 10 is not greater than the pressure outside the expanded removable polymer-coated metal balloon 18, the detachable polymer-coated metal balloon 18 is , may have sufficient strength to maintain an expanded or partially expanded configuration in vivo after separation from the catheter or catheter assembly 5 .

The removable polymer-coated metal balloon 18 may not have sufficient strength to maintain an expanded or partially expanded configuration in vivo after separation from the catheter or catheter assembly 5 . A removable polymer-coated metal balloon when no solid or semi-solid material not derived from the patient is present in the central void 115 of the expanded removable polymer-coated metal balloon 18 after separation from the first and second catheters 173 and 174. 18 may not have sufficient strength to maintain an expanded or partially expanded configuration in vivo after separation from catheter or catheter assembly 5 . When the removable polymer-coated metal balloon 18 is implanted in an unsealed configuration, the detachable polymer-coated metal balloon 18 is in an expanded or partially expanded configuration after separation from the catheter or catheter assembly 5. may not be strong enough to maintain in vivo. When the pressure in the central void 115 or interior volume of the expanded removable polymer-coated metal balloon 18 is not greater than the pressure outside the expanded removable polymer-coated metal balloon 18, the detachable polymer-coated metal balloon 18 is , may not have sufficient strength to maintain an expanded or partially expanded configuration in vivo after separation from the catheter or catheter assembly 5 .

A variety of vascular structures can be achieved by fabricating conductive mandrels 740 of various sizes and shapes, applying a metallic layer 90 by electroplating or electroforming, and then applying one or more layers 97 of non-metallic coatings or polymers. , biological conduit 900, or a removable polymer-coated metal balloon 18 that closely matches the size and shape of the biological space, saccular aneurysm 320, segment of artery 317, segment of vein 318, LAA 800. , a paravalvular leak pathway 808 , a segment of a biological conduit 900 , or a specific biological space 904 .

In some embodiments, all or part of the removable polymer-coated metal balloon 18 of the removable balloon catheter 1 is non-compliant. In some embodiments, all or part of the removable polymer-coated metal balloon 18 of the removable balloon catheter 1 expands <2% upon expansion.

In some embodiments, the outer surface of the polymer-coated metal detachable balloon 18 of the detachable balloon catheter 1 comprises a surface structure. In some embodiments, the outer surface of the polymer-coated metal detachable balloon 18 of the detachable balloon catheter 1 comprises surface structures having a height of 0.01-1 μm. In some embodiments, the proximal region 110 of the polymer-coated metal balloon 18 of the detachable balloon catheter 1 comprises surface structures or surface structures having a height of 0.01-1 μm, while the intermediate region 100 and distal region 120 are smooth or smoother than proximal region 110 . In some embodiments, the outer surface of the proximal region 110 of the polymer-coated metal balloon 18 of the detachable balloon catheter 1 configured for implantation into a saccular aneurysm 320 or LAA 800 has a surface structure or 0.01 Intermediate region 110 and distal region 120 are smooth or smoother than proximal region 110, although comprising surface structures having a height of ˜1 μm.

Removable balloon 10 further comprises an expandable metal retention structure 731, as shown in FIG. Reduce the risk of migration after placing the spatial lumens. Such a feature can provide an added factor of safety when filling or occluding a vein segment 318, for example, as the lumen diameter of the vein increases in the direction of flow, as shown in FIG. 97B. Therefore, movement of the device within the vein 318 is not self-limiting, and the device may reach the left atrium, right ventricle, or bifurcation of the pulmonary artery branch, causing symptoms of pulmonary embolism. In contrast, as shown in FIG. 97A, the lumen diameter of artery 317 generally decreases in the direction of flow. Thus, transition of the device within artery 317 is self-limiting, as shown in FIG. , may not be so important.

The expandable metal retention structure 731 can be attached to the proximal neck 130 of the removable balloon 10 as shown in FIGS. 79A and 100-103 or the distal neck 130 of the removable balloon 10 as shown in FIGS. It may be attached to either of the head sections 140 . The proximal-mounted expandable metal retention structure 731 is advantageous when the removable balloon catheter 1 is inserted in the direction of blood flow, and the distal-mounted expandable metal retention structure 731 is the removable After expansion, which is advantageous if the balloon catheter 1 is inserted in the direction opposite to the blood flow, the diameter of the portion of the metal retention structure 731 is equal to or less than the diameter of the expanded removable balloon 10 . bigger than As shown in FIG. 98B, a portion of expandable metal retention structure 731 is configured to contact vein 318, LAA 800, aneurysm 320, biological conduit 900, or other blood-containing or biological space. It is Expandable metal retention structure 731 comprises a plurality of elongated ribs 604 or elongated 730 . In the case of a proximally attached expandable metal retention structure 731, as shown in FIG. It may comprise a plurality of elongated ribs 604 extending from both rings 606 . At least one elongated rib 604 is a barb configured to engage a portion of the wall of an artery 317, vein 318, LAA 800, aneurysm 320, biological conduit 900, or other blood-containing structure or biological space. 608. In some embodiments, elongated ribs 604 are biased outward. As shown in FIG. 79B, in the case of a distally attached expandable metal retention structure 731, the expandable metal retention structure 731
It comprises a plurality of elongated arms 730 extending to proximal retaining ring 602 . A free end of at least one elongated arm 730 has a hook configured to engage an artery 317, a vein 318, an LAA 800, an aneurysm 320, a biological conduit 900, or a portion of a blood-containing structure or biological space. 733 may be included.

In some embodiments, expandable metal retention structure 731 is self-expanding. Retaining structure 731 may comprise Nitinol or stainless steel. When expanded, the outer diameter of the ring structure is in the range of 3-40 mm and the diameter of the expandable removable balloon 10 is 3-40 mm.

Detachable balloon catheter 1 comprising expandable metal retention structure 731 further comprises an outer catheter (referred to as the "third catheter"), as shown in Figures 15A-C and 16A-D. Alternatively, as shown in FIGS. 80A, 81A, 82A, 101A, 102A, and 103A, the distal portion of the third catheter 175 extends over at least a portion of the expandable retention structure 731. Pass through and retain expandable retention structure 731 in a constrained, compressed, or collapsed configuration. Third catheter 175 may further comprise a proximal hub. The proximal hub may be configured with a radiocontrast injection port 177 . The distal portion of the third catheter 175 may further comprise side holes so that at least some of the radiography injected into the ports on the hub of the third catheter 175 exits through the side holes. be able to. In some embodiments, as shown in FIGS. 80B, 81B, 82B, 101B, 102B, and 103B, the distal end of the third catheter 175 can be pulled back but constrained, compressed, Alternatively, the folded retention structure 731 remains held in place, resulting in expansion of the retention structure 731 . In some embodiments, it can be a third catheter 175 . In some embodiments, the third catheter 175 can be pulled back prior to inflation of the removable balloon 10. In some embodiments, third catheter 175 can be pulled back after expansion of removable balloon 10 .

In one embodiment, the retention structure 731 is made of a highly elastic material, such as Nitinol, and is secured from a proximal retention ring 602 engaged to the distal neck 140 of the removable balloon, as shown in FIG. 79B. It comprises a plurality of elongated arms 730 extending distally. Such an embodiment of retention structure 731 is designed to resist movement of detachable balloon 10 in which blood or other bodily fluids flow from distal neck 140 toward proximal neck 140 of detachable balloon 10 . Optimized. The distal end of each elongated arm 730 is oriented to the wall of artery 317, vein 318, LAA 800, or other blood-containing structure, biological conduit 900, or biological space when retaining structure 731 is pinched. further comprising a hook configured to engage a portion of the 80A-F, 81A-I, and 82A-I show various sequences of operation of the detachable balloon catheter 1 with such embodiments of the retaining structure 731. FIG. As shown in FIGS. 80A, 81A, and 82A, the retention structure 731 has a distal marker band 612 during delivery of the detachable balloon 10 having the retention structure 731 with the detachable balloon catheter 1. Compressed by the third catheter 175 . After confirming proper positioning, the third catheter 175 is pulled back and the retention structure 731 is expanded, as shown in FIGS. 80B, 81B, and 82B. The removable balloon 10 is then expanded as shown in Figures 80C, 81C and 82C. Optionally, as shown in FIGS. 81D-F and 82F, placement of one or more coils or elongated bodies 720 in the central void 115 of the expanded removable balloon 10 provides reinforcement against compression. Optionally, as shown in FIGS. 82D-E, one or more coils or other elongated bodies 720 (different coils or other elongated bodies 720 as disposed in the central void 115 of the expanded removable balloon 10). or either the same coil or other elongated body 720 ) facilitates embolic occlusion of the biological space distal to the expanded removable balloon 10 . The expanded removable balloon 10 is then removed from the first catheter 173, as shown in FIGS. 80D-F, 81G-I, and 82G-I.

In another embodiment, as shown in FIG. 19A, the retention structure 731 is made of a highly elastic material such as Nitinol and is a balloon detachable from a proximal retention ring 602 engaged to the first catheter 173. It comprises a plurality of elongated ribs 604 extending to a distal retaining ring 606 engaged with ten proximal necks 130 . Such an embodiment of retention structure 731 may be used to resist movement of removable balloon 10 in which blood or other bodily fluids flow from proximal neck 130 toward distal neck 130 of removable balloon 10 . optimized for When retention structure 731 is expanded, each elongated rib 604 engages the wall of artery 317, vein 318, LAA 800, or other blood-containing structure, biological conduit 900, or part of the biological space. It further comprises a barb 608 configured to. 101A-F, 102A-J, and 103A-I show various sequences of operation of the detachable balloon catheter 1 with such embodiments of the retaining structure 731. FIG. 101A, 102A, 103A, during delivery of the detachable balloon 10 having the retention structure 731 by the detachable balloon catheter 1, the retention structure 731 has a third distal marker band 612. It is compressed by catheter 175 . After confirming proper positioning, the third catheter 175 is pulled back to expand the retention structure 731, as shown in FIGS. 101B, 102B, and 103B. The removable balloon is then expanded as shown in Figures 101C, 102C and 103C. Optionally, as shown in FIGS. 102D-G and 103F, placement of one or more coils or other elongated bodies 720 in the central void 115 of the expanded removable balloon 10 provides reinforcement against compression. Optionally, one or more coils or other elongated bodies 720 (different coils or other elongated bodies 720 or the same coils or other elongated bodies 720 as disposed within the central void 115 of the expanded removable balloon 10). 720) facilitates embolic occlusion of the biological space distal to the expanded removable balloon 10, as shown in FIGS. 103D-E. The expanded detachable balloon 10 is then removed from the first catheter 173, as shown in Figures 101D-F, 102H-J, and 103G-I.

In some embodiments, the outer surface of removable balloon 10 comprises a surface structure. In certain instances, these surface structures increase the surface roughness and the outer surface of the isolated balloon and saccular aneurysms 320, arteries 317, veins 318, LAA 800, perivalvular leak pathways 808, and other blood-containing structures. , or the biological conduit 900, or space, thereby reducing the risk of motion and migration of the removable balloon 10 after deployment. In some embodiments, the surface structures have a height of 0.01-1 μm. In some embodiments, the outer surface of the removable balloon 10 comprises a rounded, pebbled, or grained structure.

In some embodiments, the outer surface of removable balloon 10 includes a lubricious coating. In particular examples, this lubricious or hydrophilic coating is applied to the outer surface of the removable balloon 10 and the saccular aneurysms 320, arteries 317, veins 318, LAA 800, paravalvular leak paths 808, etc. It reduces frictional forces between blood-containing structures or biological conduits or spaces, thereby reducing the risk of tissue damage during deployment and expansion of removable balloon 10 . In some embodiments, the lubricious or hydrophilic coating is a hydrophilic coating, SurModics, Inc. or the Serene ^™ coating from BioInteractions Ltd. Assist ^™ coating.
catheter assembly

The present disclosure provides an embodiment of a first medical device 1 comprising a removable balloon 10 and a catheter or catheter assembly 5, as shown in FIGS. 13A-D, 14A-C, 15A-C and 16A-D. Regarding. Here, the removable balloon 10 is configured to be fluidly expanded and detached from the catheter or catheter assembly 5 in vivo.

The first catheter 173 of the removable balloon catheter 1, as shown in FIGS. 13C, 14A-C and 16A-D, has a proximal end, a lumen configured to receive the second catheter 174, and a It has a distal end joined or operably connected to the proximal region 110 of the removable balloon 10 . In various embodiments, the first catheter 173 is part of the proximal neck 130 of the removable balloon 10, or part of the proximal neck assembly 135 of the removable balloon 10, or is part of the first catheter 173. It is joined to a tubular segment that is inserted between 173 and the proximal neck 130 or proximal neck assembly 135 of removable balloon 10 .

In some embodiments, the outer layer of the wall of the first catheter 173 comprises a polymer or comprises Pebax, nylon, polyimide, and PTFE. In some embodiments, the inner layer of the wall of first catheter 173 comprises a lubricious polymer, or comprises PTFE, polyimide, a blend, or a blend of polyimide and PTFE. In some embodiments, the first catheter 173 includes an intermediate layer comprising metal, the intermediate layer being located between the outer and inner layers. The middle layer metal of the first catheter 173 may be configured as wires, including metals or wires configured in spirals, coils, braids, wovens, or linear patterns, or combinations thereof. . In some embodiments, the metal or metal wire comprises nitinol or stainless steel. In some embodiments, the wire is round and has a diameter of 0.0005-0.0030 inches. In some embodiments, the wire is composed of coils having a pitch of 0.0010 to 0.0060 inches. In some embodiments, the wire is flat and has a thickness of 0.0005-0.0060 inches and a width of 0.001-0.030 inches. In some embodiments, the wire is comprised of a braid, the braid having a length per inch (PPI) of 50-300; It is wrapped with a braid in an "under one, over two" pattern. In some embodiments, the proximal portion of the wire in the first catheter 173 is flat and has a thickness of 0.0005-0.0060 inches and a width of 0.001-0.030 inches; Constructed in a braided configuration with picks per inch of length. The wire in the distal portion of the first catheter 173 is round and has a diameter of 0.0005-0.0030 inches and is configured in a coil pattern with a pitch of 0.0010-0.0060 inches.

In some embodiments, no metal or metal wire is present in the distal segment of the first catheter 173 joined to the male tubular structure, the tubular structure being shown in Figures 53A-C and 54A-C. or a thermally sensitive tubular structure 410 as shown in FIGS. 64A-D.

In some embodiments, the first catheter 173 includes a lubricious or hydrophilic coating, including a lubricious or hydrophilic coating present on the inner surface, the outer surface, or both the inner and outer surfaces of the first catheter 173. In some embodiments, a lubricious or hydrophilic coating is present on the distal portion of first catheter 173 but not on the proximal portion of first catheter 173 .

In some embodiments, the outer layer of the proximal end of the first catheter 173 comprises a material with a Shore durometer hardness of 40-90D. In some embodiments, the outer layer of the proximal end of first catheter 173 comprises nylon. In some embodiments, the outer layer of the distal end of first catheter 173 comprises a material with a Shore durometer hardness of 20-60D. In some embodiments, the outer layer of the proximal end of first catheter 173 comprises nylon.

In some embodiments, as shown in FIGS. 53B, 54B and 64A, the distal end of the first catheter 173 includes a marker band 612 that is visible during fluoroscopy, allowing the dilation balloon and the first catheter 173 to expand. is configured to identify locations where separation of the is designed to occur.

In some embodiments, first catheter 173 includes a hub and a shaft. In some embodiments, the proximal hub of first catheter 173 includes a valve including a Tuohy-Borst adapter 186 incorporating a valve. In some embodiments, FIGS. As shown at 59A-E, 64A-D, 67A-D, 70A-D and 74A-E, the first catheter 173 includes a male tubular structure joined to the distal end of the first catheter 173. and thereby forming a first catheter assembly. In some embodiments, as shown in FIGS. In addition, the outer surface of a portion of first catheter 173 or first catheter assembly is joined to a portion of the inner surface of proximal neck 130 or proximal neck assembly 135 of removable balloon 10 . In some embodiments, the first catheter 173 or a portion of the first catheter assembly is joined to a portion of the distal neck 140 or distal neck assembly 142 of the removable balloon. Although not shown, this distal joint configuration is structurally and functionally similar to the proximal joint configuration described above. In some embodiments, the outer surface of the first catheter 173 or a portion of the first catheter assembly is joined to a portion of the inner surface of the distal neck 140 or distal neck assembly 142 of the removable balloon.

In some embodiments, the inner diameter or lumen diameter of first catheter 173 is between 0.025 and 0.068 inches. In some embodiments, the outer diameter of first catheter 173 is between 0.031 and 0.096 inches. In some embodiments, the length of first catheter 173 is between 45 and 245 cm.

In some embodiments, the wall of first catheter 173 is continuous from the proximal end to the distal end. In one example, the outer layer of the proximal portion of the first catheter 173 comprises nylon with a Shore durometer hardness of 40-90D and the intermediate portion of the first catheter 173 is Pebax with a Shore durometer hardness of 20-60D. and the distal portion of the first catheter 173 comprises nylon with a Shore durometer hardness of 40-90D. As shown in FIGS. 30A-D, 31A-D, 33A-B and 34A-B, the distal portion of first catheter 173 may be a portion of proximal neck 130 or first catheter 173. and the elastomeric tubular segment 204 joined or bonded to the removable balloon proximal neck 130 or proximal neck assembly 135. It is joined to the proximal neck assembly 135 . In some embodiments, the distal portion of the first catheter 173 or the first catheter assembly of the removable balloon catheter 1 is coupled with the removable balloon distal neck 140 or distal neck assembly 142, The wall of the segment of the first catheter 173 that passes through the central void 115 or the interior volume of the removable balloon 10 contains openings for fluid to exit the lumen 163 of the second catheter 174 . Although not shown, this distal joint configuration is structurally and functionally similar to the proximal joint configuration described above. In some embodiments, as shown in FIGS. 13C and 14A-C, the proximal hub of first catheter 173 or the first catheter assembly of removable balloon catheter 1 directs fluid through a first lumen ("inflation lumen"). ) 162 for infusing (also called "inflation port") 162 .

As shown in FIGS. 13B and 14A-C, the second catheter 174 of the removable balloon catheter 1 has a proximal end, an open distal end, and a lumen 163 configured to receive the guidewire 40. have In some embodiments, the outer layer of the wall of the second catheter 174 comprises a polymer or comprises Pebax, nylon, polyimide, or PTFE. In some embodiments, the inner layer of the wall of the second catheter 174 comprises a lubricious polymer or comprises PTFE, polyimide, composite, or a mixture of polyimide and PTFE. In some embodiments, the second catheter 174 includes an intermediate layer comprising metal, the intermediate layer being located between the outer and inner layers. In some embodiments, the intermediate layer comprising metal is configured as a wire. In some embodiments, the metal-containing intermediate layer is configured in one or more of a spiral, coil, braid, woven, or linear pattern. In some embodiments, the intermediate layer comprises nitinol or stainless steel. In some embodiments, the middle layer wires are round and have a diameter of 0.0005 to 0.0030 inches. In some embodiments, the wire in the middle layer consists of coils with a pitch of 0.0010 to 0.0060 inches. In some embodiments, the middle layer wires are flat and have a thickness of 0.0005 to 0.0060 inches and a width of 0.001 to 0.030 inches. In some embodiments, the wires in the middle layer consist of braids with 50-300 picks per inch (PPI) or "under one , over two)” pattern. In one example, the wires in the middle layer of the proximal portion of the second catheter 174 are flat, 0.0005-0.0060 inches thick, 0.001-0.030 inches wide, and 0.001-0.030 inches long. The braid consists of 50-300 picks per inch. The wires in the middle layer of the distal portion of the second catheter 174 are round, have a diameter of 0.0005 to 0.003 inches, and are configured in a coil pattern with a pitch of 0.0010 to 0.0060 inches. In some embodiments, the second catheter 174 includes a lubricious or hydrophilic coating or includes a lubricious or hydrophilic coating on the inner surface, the outer surface, or both the inner and outer surfaces of the second catheter 174 . Lubricious or hydrophilic coatings include Serene coatings from SurModics Inc. In some embodiments, a lubricious or hydrophilic coating is present on the distal portion of second catheter 174 but not on the proximal portion of second catheter 174 . In some embodiments, the proximal end of second catheter 174 comprises a material with a Shore durometer hardness of 40-90D. In some embodiments, the outer layer of the proximal end of second catheter 174 comprises nylon. In some embodiments, the proximal end outer layer of the second catheter 174 comprises nylon having a Shore durometer hardness of 40-90D. In some embodiments, the distal end of the second catheter 174 comprises a material with a Shore durometer of 20-60D or Pebax with a Shore durometer of 20-60D. In some embodiments, the distal end of the second catheter 174 comprises a material with a Shore durometer of 40-90D or nylon with a Shore durometer of 40-90D. In some embodiments, the second catheter 174 includes at least two marker bands 612 that are visible during fluoroscopy to assist passage of the coil through the lumen of the second catheter 174 and to configured to assist in detachment of a coil passed through. In some embodiments, the first marker band 612 is 0.3-1.5 mm from the distal end of the second catheter 174 and the second marker band 612 is distal to the second catheter 174. 2.0-4.0 mm proximal to the proximal end. In some embodiments, the inner diameter or lumen diameter of the second catheter 174 is between 0.025 and 0.068 inches. In some embodiments, the inner diameter or lumen diameter of the second catheter 174 is between 0.012 and 0.048 inches. In some embodiments, the outer diameter of second catheter 174 is between 0.018 and 0.068 inches. In some embodiments, second catheter 174 includes a hub and a shaft. In some embodiments, the length of second catheter 174 is 50-250 cm. In some embodiments, the wall of second catheter 174 is continuous from the proximal end to the distal end. In some embodiments of the removable balloon catheter 1, the wall of the segment of the second catheter 174 that passes through the central void 115 or interior volume of the balloon provides openings for fluid to exit the lumen of the second catheter 174. include. In one example, the outer layer of the proximal portion of the second catheter 174 comprises a material with a Shore durometer hardness of 40-90D and the outer layer of the distal end of the second catheter 174 comprises a material with a Shore durometer hardness of 40-90D. and comprising a material having a Shore durometer hardness of 20-60D is sandwiched between segments of a material having a Shore durometer hardness of 40-90D. In another example, the outer layer of the proximal portion of the second catheter 174 comprises nylon having a Shore durometer hardness of 40-90D and the outer layer of the distal end of the second catheter 174 has a Shore durometer hardness of 20-60D. Pebax at the distal end of the second catheter 174 is sandwiched between segments of nylon with a Shore durometer hardness of 40-90D. In some embodiments, the distal portion of the second catheter 174 of the detachable balloon catheter 1 is coupled or operatively coupled to a portion of one or more elastomeric valves 192 by a friction fit 202. Combined. In some embodiments, the distal portion of the second catheter 174 of the detachable balloon catheter 1 is joined or operatively connected to a portion of one or more elastomeric valves by a friction fit 202, An elastomeric valve 192 is contained within a distal nosecone 191 that is coupled to a removable balloon distal neck 140 or distal neck assembly 142 . In some embodiments, the distal portion of the second catheter 174 of the removable balloon catheter 1 is joined or operable to one or more elastomeric valves 192 and portions of spacers 196 and 197 by a friction fit 202. connected to In some embodiments, the distal portion of the second catheter 174 of the removable balloon catheter 1 is joined or operable to one or more elastomeric valves 192 or portions of spacers 196 and 197 by a friction fit 202. The elastomeric valve 192 and spacers 196 and 197 are contained within a distal nosecone 191 that is coupled to the distal neck 140 or distal neck assembly 142 of the removable balloon. In some embodiments, the distal portion of the second catheter 174 of the removable balloon catheter 1 is joined or operably coupled to a portion of one or more elastomeric valves 192 by a friction fit 202, A second catheter 174 having a Shore durometer hardness of 40-90D in which one or more elastomeric valves 192 and one or more spacers 196 and 197 are inserted into a second catheter 174 material having a Shore durometer hardness of 20-60D. material segment. In some embodiments, the distal portion of second catheter 174 of detachable balloon catheter 1 is angled. In some embodiments, the angle between the distal portion of the second catheter 174 and the proximal portion of the second catheter 174 of the detachable balloon catheter 1 is between 1 and 70 degrees. In some embodiments, the proximal hub of the second catheter 174 of the detachable balloon catheter 1 is configured for infusion of fluid into the second lumen. In some embodiments, the color of the outer surface of first catheter 173, second catheter 174, or third catheter 175 is configured to help the physician use the device safely. In some embodiments, the color of the most proximal portion of the second catheter 174 is one color (the first color) and the more distal portion of the second catheter 174 is another color (the second color). color). The length of the most proximal portion is from the distal end of the (wrapped) second catheter 174 to the distal end of the male tubular structure 510, or the (wrapped) second from the distal end of the catheter 174 to a position 1-10 mm distal to the distal end of the male tubular structure 510, so that while the second catheter 174 is retracted Finally, when the physician sees the second color, retraction is stopped to avoid inadvertent dislodgment of balloon 510 . In some embodiments, the flexible elongated structure is joined to the hub 179 of the first catheter 173 and the hub 178 of the second catheter 174 to extend the length of the flexible elongated structure. The length is from the distal end of the (wrapped) second catheter 174 to the distal end of the male tubular structure, or from the distal end of the (wrapped) second catheter 174 to the male tubular structure. It may accommodate lengths from 1 to 10 mm distal to the distal end of 510, whereby the flexible, elongated structure allows the physician to move the second catheter 174 while retracting it. It prevents over retraction of 174 and inadvertent disengagement of balloon 510 . To proceed with the removal, the physician may first remove, disconnect, or cut the flexible elongated structure, and then withdraw the second catheter 174 further.

The third catheter 175 of the removable balloon catheter 1 has a proximal end, an open distal end and a lumen 164 configured to receive the first catheter 173 . The inner surface of the third catheter 175 and the outer surface 173 of the first catheter extend from the proximal hub 180 of the third catheter 175 to the distal end of the third catheter 175 and to the distal end of the third catheter 175. A third lumen 164 is defined to allow fluid passage to the adjacent space. In some embodiments, the third lumen 164 is configured for injection of fluids including water, saline, radiocontrast agents, solutions containing therapeutic agents or drugs, and mixtures therein. In some embodiments, the outer layer of the wall of the third catheter 175 comprises a polymer, Pebax, nylon, polyimide, or PTFE. In some embodiments, the inner layer of the wall of the third catheter 175 comprises a lubricious polymer, PTFE, polyimide, or composite, or a mixture of polyimide and PTFE. In some embodiments, the third catheter 175 comprises an intermediate layer comprising metal, the intermediate layer being located between the outer and inner layers. In some embodiments, the intermediate layer metal is configured as a wire. In some embodiments, the middle layer metal wire is configured in a spiral, coil, braid, woven, or linear pattern. In some embodiments, the middle layer metal or metal wire comprises nitinol or stainless steel. In some embodiments, the middle layer metal wire is round and has a diameter of 0.0005 to 0.0030 inches. In some embodiments, the middle layer metal wire consists of coils with a pitch of 0.0010 to 0.0060 inches. In some embodiments, the middle layer metal wire is flat and has a thickness of 0.0005 to 0.0060 inches and a width of 0.001 to 0.030 inches. In some embodiments, the middle layer metal wire is comprised of braids with a length "picks per inch" (PPI) between 50 and 300, and is "one under and over two". contains a braid wrapped in a pattern of For example, the wires in the proximal portion of the third catheter 175 are flat, 0.0005 to 0.0060 inches thick, 0.001 to 0.030 inches wide, and of picks are configured in a braid configuration with 50-300. The wire in the distal portion of the third catheter 175 is round and has a diameter of 0.0005-0.003 inches and is configured in a coil pattern with a pitch of 0.0010-0.0060 inches. In some embodiments, the third catheter 175 includes a lubricious or hydrophilic coating present on the inner surface, the outer surface, or both the inner and outer surfaces of the third catheter 175 . In some embodiments, the third catheter 175 includes a Serene coating from SurModics. In some embodiments, a lubricious or hydrophilic coating is present on the distal portion of third catheter 175 but not on the proximal portion of third catheter 175 . In some embodiments, the proximal end catheter 175 of the third catheter comprises a material with a Shore durometer hardness of 40-90D. In some embodiments, the outer layer of the proximal end of third catheter 175 comprises nylon. In some embodiments, the proximal end outer layer of the third catheter 175 comprises nylon having a Shore durometer hardness of 40-90D. In some embodiments, the distal end of the third catheter 175 comprises a material with a Shore durometer hardness of 20-60D. In some embodiments, the outer layer of the distal end of the third catheter 175 comprises Pebax. In some embodiments, the outer layer of the distal end of the third catheter comprises Pebax having a Shore durometer hardness of 40-90D. In some embodiments, the distal end of third catheter 175 comprises a marker band 612 that is visible under fluoroscopy and configured to identify the location of the tip of third catheter 175 . In some embodiments, the inner diameter or lumen diameter of the third catheter 175 is between 0.033 and 0.098 inches. In some embodiments, the outer diameter of third catheter 175 is between 0.039 and 0.114 inches. In some embodiments, the third catheter 175 includes a proximal hub 180 and a shaft. In some embodiments, the length of third catheter 175 is between 40 and 235 cm. In some embodiments, the wall of the third catheter 175 is continuous from the proximal end to the distal end. In some embodiments, the wall of the distal portion of third catheter 175 includes openings for fluid to exit lumen 164 of third catheter 175 .

In some embodiments, detachable balloon catheter 1 includes detachable balloon 10 and catheter assembly 5 . In some embodiments of the removable balloon catheter 1, including the catheter assembly 5, the first lumen is defined by an annular gap between the inner surface of the first catheter 173 and the outer surface of the second catheter 174. . In some embodiments of the detachable balloon catheter 1 comprising the catheter assembly 5, fluid communication is provided between the proximal hub 179 of the first catheter 173, the first lumen 162, and the central void 115 or interior volume of the balloon. It can be performed. In some embodiments of the detachable balloon catheter 1, including the catheter assembly 5, the inner diameter of the first catheter 173 is 0.003 to 0.012 inches larger than the outer diameter of the second catheter 174. In some embodiments of detachable balloon catheter 1 including catheter assembly 5 , second lumen 163 is defined by the inner surface of second catheter 174 . Some embodiments of the detachable balloon catheter 1 comprising the catheter assembly 5 provide fluid communication between the proximal hub 178 of the second catheter 174 and the space adjacent the distal end of the second catheter 174. It can be carried out. In some embodiments of detachable balloon catheter 1 including catheter assembly 5 , a portion of second catheter 174 is inserted through one or more elastomeric or elastic valves 192 . In some embodiments of the detachable balloon catheter 1, including the catheter assembly 5, the outer surface of a portion of the second catheter 174 is in contact with the inner surface of one or more elastomeric valves 192. In some embodiments of detachable balloon catheter 1 with catheter assembly 5 , one or more elastomeric valves 192 seal against second catheter 174 . In some embodiments of detachable balloon catheter 1 including catheter assembly 5 , second catheter 174 is longer than first catheter 173 . In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, the second catheter 174 is longer than the first catheter 173 and the first catheter 173 is longer than the third catheter 175. . In some embodiments of the removable balloon catheter 1, including the catheter assembly 5, the wall of the first catheter 173 is continuous from the proximal end to the distal end and the wall of the second catheter 174 is proximal It is continuous from end to distal end. In some embodiments of the removable balloon catheter 1 comprising the catheter assembly 5, the wall of the first catheter 173 is continuous and the segment of the second catheter 174 passing through the central void 115 or interior volume of the balloon 10. The wall of the includes openings for fluid to exit the lumen 162 of the second catheter 174 . In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, the proximal hub 178 of the second catheter 174 is proximal to the proximal hub 179 of the first catheter 173 and the second A portion of catheter 174 passes through lumen 162 of first catheter 173 and the distal end of second catheter 174 is distal to the distal end of first catheter 173 . In some embodiments of the detachable balloon catheter 1 with catheter assembly 5, a portion of the second catheter 174 is a valve or Tuohy-Borst with a valve joined to the hub 179 of the first catheter 173. Pass through adapter 186 . In some embodiments of the detachable balloon catheter 1 with catheter assembly 5, the outer surface of a portion of the second catheter 174 contacts the inner surface of the valve. In some embodiments of detachable balloon catheter 1 including catheter assembly 5 , a portion of second catheter 174 is received within distal neck 140 of balloon 10 . In some embodiments of detachable balloon catheter 1 including catheter assembly 5 , a portion of second catheter 174 passes through distal neck 140 of balloon 10 . In some embodiments of the detachable balloon catheter 1, including the catheter assembly 5, the inner diameter of the distal neck 140 of the balloon 10 is 0.001, 0.002, 0.001, 0.002, 0.002, 0.001, 0.001, 0.002, 0.000, 0.000, 0.000, 0.000, 0.000, 0.000, 0.000, 0.000, 0.000, 0.000, 0.000, 0.000, 0.00, 0.00 0.003 or 0.004 inches. In some embodiments of the detachable balloon catheter 1 with catheter assembly 5, a portion of the second catheter 174 is a ring structure, tubular structure, nesting structure joined to the distal balloon neck 140. It is received within a telescoping structure, catheter segment, or telescoping catheter segment 185 . In some embodiments of the detachable balloon catheter 1, including the catheter assembly 5, a portion of the second catheter 174 is a ring structure, a tubular structure, a telescoping structure, a catheter It is inserted through a segment, or telescoping catheter 185 . Some embodiments of the detachable balloon catheter 1, including the catheter assembly 5, include a ring structure, tubular structure, telescoping structure, catheter segment, or telescoping catheter segment 185 joined to the distal neck 140 of the balloon 10. is 0.001 to 0.004 inches larger than the outer diameter of the second catheter 174 . Some embodiments of the removable balloon catheter 1, including the catheter assembly 5, are a ring structure, a tubular structure, a telescoping structure, a catheter segment, or a telescoping catheter segment joined to the distal neck 140 of the balloon 10. The length is 0.3-6.0 mm.

In some embodiments of detachable balloon catheter 1 including catheter assembly 5 , the proximal hub of third catheter 175 may be joined to proximal hub 179 of first catheter 173 . In some embodiments of the detachable balloon catheter 1 including catheter assembly, the engagement or mating of the proximal hubs 179 and 180 of the first and third catheters 173 and 175 allows fluid to flow into the third lumen 164. prevent or reduce leakage during injection of In some embodiments of the detachable balloon catheter 1, including the catheter assembly 5, once coupled, the proximal hub 180 of the third catheter 175 and the proximal hub 179 of the first catheter 173 are separated. or may be separated after rotating the lock. In some embodiments of the detachable balloon catheter 1, including the catheter assembly 5, the third catheter 175 may be advanced or retracted while the first catheter 173 remains fixed in place. In some embodiments of the detachable balloon catheter 1, including the catheter assembly 5, when the proximal hub 180 of the third catheter 175 and the proximal hub 179 of the first catheter 173 are separated, the third catheter 175 can be advanced or retracted while the first catheter 173 remains fixed in place. In some embodiments of the detachable balloon catheter 1, including the catheter assembly 5, when the proximal hub 180 of the third catheter 175 and the proximal hub 179 of the first catheter 173 are separated, the third catheter 175 The proximal hub 180 of the includes a valve to prevent leakage during infusion of fluid into the third lumen. In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, the proximal hub 180 of the third catheter 175 includes a Tuohy-Borst adapter 186 with a valve. In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, the first portions of the first and second catheters 173 and 174 are connected to the valve or Tuohy-Borst adapter 186 of the third catheter 175. pass. In some embodiments of the removable balloon catheter 1, including the catheter assembly 5, a portion of the outer surface of the first catheter 173 contacts the inner surface of the valve. In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, the proximal hub 179 of the first catheter 173 and the proximal hub 178 of the second catheter 174 are proximal to the third catheter 175. Proximal to hub 180 . In some embodiments of the detachable balloon catheter 1 including the catheter assembly 5, portions of the first and second catheters pass 173 and 174 through the proximal hub 180 of the third catheter 175. . In some embodiments of detachable balloon catheter 1 including catheter assembly 5 , portions of first and second catheters 173 and 174 pass through lumen 164 of third catheter 175 . In some embodiments of detachable balloon catheter 1 including catheter assembly 5 , portions of first and second catheters 173 and 174 are distal to the distal end of third catheter 175 . In some embodiments, proximal hub 180 of third catheter 175 of detachable balloon catheter 1 includes port 177 for infusion of fluid into third lumen 164 .
Attachment/Detachment System

The present disclosure relates to a medical device 1 comprising a removable balloon 10 and a catheter or catheter assembly 5, wherein the removable balloon 10 is configured to separate from the catheter or catheter assembly 5 in vivo. In some embodiments, as shown in FIGS. The distal end and a portion of the balloon proximal neck assembly 135 combine to form a mechanical attachment 500 between the first catheter 173 and the balloon 10 . As shown in Figures 17A, 18A, and 20A-C, the mechanical attachment is configured to engage as the second catheter 174 passes through the attachment site, and Figures 17B-C, 18B. D, and 20D-E, it is configured to disengage when the second catheter 174 is removed from the attachment site.

In some embodiments, removable balloon 10 is actuated from first catheter 173 by opening and closing a mechanical latch 500, as shown in FIGS. 17A-C, 18A-D and 20A-E. Possibly coupled and uncoupled. Mechanical latch 500 includes a tubular male structure 510 coupled to the distal end of first catheter 173 . As shown in FIGS. 26A-H and 27, male tubular structure 510 defines a removable assembly lumen extending from male proximal end 506 to female distal end 508 . Male distal end 508 includes at least one movable arm 512 having distal tabs 513 projecting radially outwardly from its outer surface. Between arms 512 are longitudinal recesses 514 that allow fluid to flow radially through male tubular structure 510 . By way of example and not limitation, nominal dimensions for various potential embodiments of the male tubular structure 510 shown in FIGS. 26A-H, and acceptable and preferred dimension ranges are presented in tabular form in FIG. . The mechanical latch 500 further comprises a female tubular structure 520 coupled to the proximal neck 130 or proximal neck assembly 135 of the balloon. Female tubular structure 520 defines a second removable assembly lumen extending from a female proximal end 524 to a female distal end 528 as shown in FIGS. 28A-28G and 29 . The nominal dimensions of various potential embodiments of the female tubular structure 510 described in FIGS. 28A-28G, and acceptable and preferred dimension ranges are presented in tabular form in FIG.

The male tubular structure may also have two arms and tabs, four arms and tabs, five arms and tabs, or six arms and tabs 528 . The second catheter 174 of the detachable balloon catheter 1 is configured such that the male tubular structure 510 can be secured to the female tubular structure 520 in one configuration and the male tubular structure 510 in a second configuration. are free to move relative to the female tubular structure 520 . A male tubular structure 510 is received within the second removable assembly lumen of the female tubular structure 520 and a portion of the shaft of the second catheter 174 is inserted into the first removable assembly of the male structure. When received within the lumen, second catheter 174 exerts a radially outward force on at least one arm of male tubular structure 510 causing male tubular structure 510 to join female tubular structure 520 . resulting in an engagement configuration that is The male tubular structure 510 is received within the second removable assembly lumen of the female tubular structure 520 and the shaft of the second catheter 174 extends from within the first removable assembly lumen of the male structure. When withdrawn, the removable assembly changes from an engaged configuration to a non-engaged configuration and the assembly of first catheter 173 and male tubular structure 510 merges with female tubular structure 520 and balloon proximal neck 130 . assembly and the first catheter 173 and balloon 10 can be pulled apart. In some embodiments, the inner diameter of female tubular structure 520 is 0.0005, 0.001, 0.002 or 0.003 inches greater than the outer diameter of male tubular structure 510, and the male tubular structure The body and female tubular structures 510 and 520 are capable of slip-fit engagement. In some embodiments, male tubular structure 510 and female tubular structure 520 are manufactured by machining, casting, or other suitable method. In some embodiments, the proximal end of female tubular structure 520 includes an annular flange 526 . In some embodiments, male tubular structure 510 includes one or more depth stop projections extending from its outer surface, and annular flange 526 of male tubular structure 520 includes one or more depth stop projections. Defining corresponding depth stop recesses 514, the depth stop projections of male tubular structure 510 are received in the depth stop recesses 514 of female tubular structure 520, and the female structure 520 restricts insertion of male structure 510 into the . Depth stop projections of male tubular structure 510 and corresponding depth stop recesses 514 of female tubular structure 520 are operatively engaged such that rotation of male structure 510 causes female structure 520 to move. rotate. In some embodiments, male tubular structure 510 comprises metal, radiopaque metal, nitinol, stainless steel, platinum, iridium, gold, silver, titanium, or combinations or alloys thereof. In some embodiments, female tubular structure 520 comprises metal, radiopaque metal, platinum, iridium, gold, silver, stainless steel, nitinol, titanium, or alloys or combinations thereof. In some embodiments, male tubular structure 510 comprises two movable arms 512 . In some embodiments, two movable arms 512 are positioned at the antipodal point at the distal end of male tubular structure 510 . In some embodiments, male tubular structure 510 includes three movable arms 512 . In some embodiments, the three movable arms 512 are positioned at equidistant points on the distal end 508 of the male tubular structure 510 . In some embodiments, at least one movable arm 512 of male tubular structure 510 is biased inwardly when the removable assembly is in the disengaged configuration. In some embodiments, the at least one movable arm 512 of the male tubular structure 510 is biased inwardly when the removable assembly is in the disengaged configuration and the removable assembly is in the engaged configuration. At some point, it is displaced radially outward. At least a portion of the distal tab 513 of at least one of the movable arms 512 of the male tubular structure 510 engages at least one of the distal ends 528 of the female tubular structure 520 when the removable assembly is in the engaged configuration. and at least a portion of one distal tab 513 of at least one movable arm 512 of male tubular structure 510 extends beyond at least a portion of the outer surface of female tubular structure 520. It extends radially, thereby retaining the male tubular structure 510 within the female tubular structure 520 . When the second catheter 174 is withdrawn from within the first removable assembly lumen of the male structure and the removable assembly changes from the engaged configuration to the disengaged configuration, the first catheter and male tubular structure The assembly of body 510 can be separated from the assembly of proximal neck 130 of balloon 10 and female tubular structure 520 by pulling first catheter 173 and balloon 10 apart.

In some embodiments, the inner diameter or lumen diameter of male tubular structure 510 is between 0.025 and 0.068 inches. In some embodiments, the outer diameter of male tubular structure 510 is between 0.028 and 0.093 inches. In some embodiments, the inner and outer diameters of female tubular structure 520 are between 0.031 and 0.096 inches.

In one embodiment, the attachment and detachment assembly of the detachable balloon catheter 1 includes mated parts. A male tubular structure is received within the female tubular structure. A male tubular structure is a generally tubular structure having walls that define a lumen or conduit. A lumen extends from the proximal end to the distal end of male tubular structure 510 . The lumen is dimensioned to receive a moveable second catheter 174 while also providing a conduit for fluid through the detachment assembly for inflation of the detachable balloon. The male and female tubular structures are machined to close tolerances to engage each other in a slip fit engagement.

The proximal end of the male tubular structure is received and coupled to the distal end of the delivery device. The distal end of the male tubular structure is defined by two or more fingers 513 that may have different lengths in various embodiments. Each finger 513 has an outward projection that extends beyond the outer diameter of the wall. Specifically, fingers 513 are biased inward toward the central axis of the male tubular structure. As such, the projection generally does not extend beyond the outer diameter of the wall without exerting a radially outward force. A radially outward force is provided by the moveable second catheter 174 when positioned within the assembly to retain the male tubular structure to the female tubular structure. In one aspect, moveable second catheter 174 directly applies a radially outward force to at least one of fingers 513 . Another embodiment of the male tubular structure also includes support bars 516 positioned between fingers 513 . As the second catheter 174 is withdrawn, the support bar 516 aids in the alignment of the male and female tubular structures 510, 520 and also prevents the guidewire 40 from entangling the separation assembly.

The wall also includes one or more depth stop projections that engage complementary recesses 514 in the proximal face of the female tubular structure. In addition to restricting insertion of the male tubular structure into the female tubular structure, the depth stop protrusion also allows rotation of the female tubular structure and removable balloon as the delivery device rotates. do. In various embodiments, the male tubular structure is constructed of nitinol or stainless steel. When the mechanical latches are engaged, the annular shoulder of the male part inter alia contacts the annular shoulder of the female part, causing axial compression from the first catheter 173 to the proximal neck 130 of the removable balloon 10. power can be transmitted.

Female tubular structure 520 includes a tubular wall defining a lumen dimensioned to receive the male tubular structure. The proximal end of the female tubular structure includes an annular flange that defines one or more recesses 514 . The distal end of the female tubular structure is coupled to the removable balloon proximal neck 130 . In various embodiments, the female tubular structure is composed of radiopaque metals including, but not limited to, platinum, rhodium, or alloys thereof.

The second catheter 174 is withdrawn from the first catheter 173 to allow removal of the detachable balloon 10 from the first catheter 173 . This action eliminates interference between fingers 513 of male component 510 and distal edge 530 of female component 520 . The first catheter 173 is then withdrawn, releasing the mechanical latch 500 . Note that the separation process may be performed with the guidewire 40 in place, as shown in FIGS. 17A-17C, or without the guidewire 40 in place, as shown in FIGS. 18A-18D. should. It should also be noted that a coil or other elongated or expandable body 720 may be used in place of the guidewire 40 to perform the separation process. Mechanical latches 500 may be used to attach detachable balloons 10 and other expandable bodies of various sizes and shapes to catheter systems.

Mechanical latch 500 is positioned within balloon 10 as shown in FIGS. 22A-22I and 23A-23H when used alone as shown in FIGS. 19A-19G and 20A-20E. 1 when used in combination with one or more elongated bodies 720, or positioned both within and distal to balloon 10 as shown in FIGS. 24A-24I and 25A-25I. Compatible with deployment of removable balloon 10 when used in combination with one or more elongated bodies 720 .

Figures 19A-19G and 20A-20E illustrate a first sequence of operation of the detachable balloon catheter 1 with a mechanical latch 500 attachment system according to one embodiment. A balloon 10 is deployed and inflated. Guidewire 40 is retracted. A second catheter 174 is withdrawn from the male and female tubular structures 510 and 520 of the latch, separating the first catheter 173 from the proximal neck 130 of the balloon 10 . Finally, the first catheter 173 is withdrawn.

Figures 21A-21E and 22A-22I illustrate a second sequence of operation of the detachable balloon catheter 1 with a mechanical latch 500 attachment system according to one embodiment. A balloon 10 is deployed and inflated. The second catheter 174 is retracted from the latch male and female tubular structures 510 and 520 to separate the first catheter 173 from the proximal neck 130 of the balloon 10 . First catheter 173 is withdrawn. Finally, the guidewire 40 is withdrawn.

Figures 22A-22I and 23A-23H illustrate a third operating sequence for the detachable balloon catheter 1 with a mechanical latch 500 attachment system according to one embodiment. A balloon 10 is deployed and inflated. Guidewire 40 is retracted. Second catheter 174 is partially retracted. One or more coils or first elongated body 720 are positioned within central void 115 of expanded balloon 10 . The second catheter 174 is retracted from the latch male and female tubular structures 510 and 520 to separate the first catheter 173 from the proximal neck 130 of the balloon 10 . Finally, the first catheter 173 is withdrawn.

Figures 24A-24I and 25A-25I show a fourth sequence of operation of the detachable balloon catheter 1 with a mechanical latch 500 attachment system according to one embodiment. A balloon 10 is deployed and inflated. Guidewire 40 is retracted. A coil or portion of the first elongated body 720 is positioned distal to the expanded balloon 10 . Second catheter 174 is partially retracted. The remaining portion of first elongated body 720 is disposed within central void 115 of expanded balloon 10 . The second catheter 174 is retracted from the latch male and female tubular structures 510 and 520 to separate the first catheter 173 from the proximal neck 130 of the balloon 10 . Finally, the first catheter 173 is withdrawn.

The present disclosure relates to a medical device comprising a removable balloon 10 and a catheter or catheter assembly 5, wherein the removable balloon 10 is configured to separate from the catheter or catheter assembly 5 in vivo. In some embodiments, balloon 10 is joined or operatively connected to first catheter 173 by an elastomeric tubular structure 204 .

In some embodiments, elastic tubular segment 204 is coupled to proximal neck 130 of balloon 10 and configured for a friction fit with the distal end of first catheter 173 . In some examples, the detachable balloon of detachable balloon catheter 1 can be placed in artery 317, vein 318, LAA 800, aneurysm 320, biological conduit 900, or other blood-containing or biological space 904. At least a portion of the outer surface of the expanded detachable balloon 10 or a portion of the outer surface of the expandable retention structure 731 attached to the balloon 10 may be artery 317 , vein 318 , LAA 800 , aneurysm 320 , biological conduit 900 . , or other blood-containing or biological space 904, and is in contact with at least a portion of the wall of the body space 904, by pulling the first catheter 173 away from the proximal neck 130 of the balloon 10 and elastomeric tubular structure 204 assembly. One catheter 173 is separated from the proximal neck 130 assembly of the balloon 10 and the elastomeric tubular segment 204 . In some embodiments, the elastomeric tubular structure 204 is configured to create a friction fit 202 with the distal end of the first catheter 173, and the removable balloon is adapted to artery, vein, LAA800, aneurysm 320. , biological conduit 900, or other blood-containing or biological space, such that at least a portion of the outer surface of the balloon, or a portion of the outer surface of the expandable retention structure 731 attached to the balloon, is in contact with the arterial wall 317, the vein. 318 , the first catheter 173 is positioned at the proximal neck 130 of the removable balloon 10 when in contact with at least a portion of the walls of the LAA 800 , aneurysm 320 , biological conduit 900 , or other blood-containing or biological space 904 . The first catheter 173 may be separated from the proximal neck 130 assembly of the removable balloon 10 and the elastomeric tubular segment 204 by pulling the first catheter 173 away from the assembly and the elastomeric tubular segment 204 . In some embodiments, the distal end of elastomeric tubular segment 204 is inserted into proximal neck 130 or proximal neck assembly 135 of removable balloon 10 and elastomeric tubular segment 204 is proximal to removable balloon 10 . It is coupled to the inner surface of proximal neck 130 or proximal neck assembly 135 . In some embodiments, the distal end of the elastomeric tubular structure 204 is inserted over the balloon proximal neck 130 or proximal neck assembly 135 and the first tubular structure is inserted over the balloon proximal neck 130 or It is coupled to the outer surface of proximal neck assembly 135 . In some embodiments, the distal portion of the elastomeric tubular segment 204 is glued or adhesively attached to the removable balloon proximal neck 130 or proximal neck assembly 135 . In some embodiments, when the detachable balloon catheter 1 is assembled, the proximal end of the elastomeric tubular structure 204 is open and extended, and the distal end of the first catheter 173 is an extended first friction fit 202. It is inserted into the proximal end of the structure and forms a friction fit 202 between the proximal portion of elastomeric tubular structure 204 and the distal portion of first catheter 173 . In some embodiments, the outer surface of a ring structure, tubular structure, telescoping structure, catheter segment, or telescoping catheter segment is joined to the inner surface of the proximal neck 130 to form the proximal neck assembly 135 and frictionally A mating structure is adhered or bonded to the ring structure, tubular structure, telescoping structure, catheter segment, or telescoping catheter segment. In some embodiments, the inner surface of a ring structure, tubular structure, telescoping structure, catheter segment, or telescoping catheter segment is joined to the outer surface of proximal neck 130 to form proximal neck assembly 135 . In some embodiments, the ring structure, tubular structure, telescoping structure, catheter segment, or telescoping catheter segment is made of metal, platinum, iridium, gold, silver, stainless steel, nitinol, titanium or alloys, or Including combinations. In some embodiments, at least a portion of the ring structure, tubular structure, telescoping structure, catheter segment, or telescoping catheter segment is radiopaque and visible under fluoroscopy and the first It can assist the physician in confirming that the catheter 173 has separated from the removable balloon 10 . In some embodiments, the friction fit 202 between the elastomeric tubular structure 204 and the first catheter 173 is made without glues, adhesives or welding.

In some embodiments, the elastomeric tubular structure 204 is adhered to the distal end of the first catheter 173 and the removable balloon is attached to an artery, vein, LAA 800, aneurysm 320, biological conduit 900, or At least a portion of the outer surface of the balloon, or the A portion of the outer surface of expandable retention structure 731 attached to the wall of artery 317, vein 318, LAA 800, aneurysm 320, biological conduit 900, or other blood-containing or biological space 904. By contacting at least a portion and pulling apart the assembly of first catheter 173 , elastomeric tubular structure 204 and removable balloon 10 , elastomeric tubular structure 204 is separated from proximal neck 130 of removable balloon 10 . can be separated. In some embodiments, the proximal end of the elastomeric tubular structure 204 is inserted into the distal end of the first catheter 173 and the elastomeric tubular structure 204 rests on the inner surface of the distal end of the first catheter 173. spliced. In some embodiments, the proximal end of the elastomeric tubular structure 204 is inserted over the distal end of the first catheter 173 and the elastomeric tubular structure 204 covers the outer surface of the distal end of the first catheter 173. is spliced to In some embodiments, elastomeric tubular structure 204 is adhered to the distal end of first catheter 173 with glue or adhesive. In some embodiments, when assembling the detachable balloon catheter 1 , the distal end of the elastomeric tubular structure 204 is stretched open to open the proximal neck 130 or proximal neck assembly 135 of the detachable balloon 10 . inserted into the stretched open elastomeric tubular structure 204 to form a friction fit 202 between the distal portion of the elastomeric tubular structure 204 and the proximal neck 130 or proximal neck assembly 135 of the removable balloon 10; . In some embodiments, the inner surface of the ring structure, tubular structure, telescoping structure, catheter segment, or telescoping catheter segment 190 is joined to the outer surface of the proximal neck 130 of the removable balloon 10 and the proximal neck An assembly 135 is formed. In some embodiments, the ring structure, tubular structure, telescoping structure, catheter segment, or telescoping catheter segment 190 is made of metal, platinum, iridium, gold, silver, stainless steel, nitinol, titanium or alloys, or thereof. including combinations of In some embodiments, at least a portion of the ring structure, tubular structure, telescoping structure, catheter segment, or telescoping catheter segment 190 is radiopaque and visible under fluoroscopy and the first catheter 173 has separated from the removable balloon 10. In some embodiments, the friction fit 202 between the elastomeric tubular structure 204 and the proximal neck 130 or proximal neck assembly 135 of the removable balloon 10 is made without glue, adhesive or welding.

In some embodiments, elastomeric tubular segment 204 is a sleeve or wrap. In some embodiments, elastomeric tubular segment 204 is elastic or resilient. In some embodiments, elastomeric tubular segment 204 comprises an elastomeric or elastic material. In some embodiments, elastomeric tubular structure 204 comprises a biocompatible thermoplastic elastomeric material. In some embodiments, elastomeric tubular segment 204 comprises nylon, Pebax, polyurethane, thermoplastic polyurethane, silicone, chronoprene, or other biocompatible elastomeric or elastic material. In some embodiments, elastomeric tubular segment 204 comprises a material having a Shore durometer between 25D and 80D.

By way of example and not limitation, nominal dimensions and acceptable preferred dimension ranges for various potential embodiments of the elastomeric tubular segment 204 described in FIGS. 42A-42C are presented in tabular form in FIG. In some embodiments, the outer diameter of elastomeric tubular segment 204 is between 0.031 and 0.096 inches after insertion of first catheter 173 . In some other embodiments, the outer diameter of elastomeric tubular segment 204 is 0.035 to 0.100 inches after insertion of first catheter 173 .

In the elastomeric tubular segment 204, the separation process is with or in the presence of a guidewire 40 extending through the central void 115 of the expanded removable balloon and terminating distally of the expanded removable balloon. Note that this can happen without It should also be noted that the detachment process can occur with a coil or other elongated or expandable body 10 within the lumen of first catheter 173 or second catheter 174 . Elastomeric tubular structure 204 may be used to mount removable balloons 10 of various sizes and shapes.

Elastomeric tubular segment 204 was positioned within balloon 10 as shown in FIGS. 38A-38J and 39A-39H when used alone as shown in FIGS. 36A-36F and 37A-37E. When used in combination with one or more first elongate bodies 720, or positioned both within and distal to balloon 10 as shown in FIGS. 40A-40K and 41A-41H. Adapted for deployment of the removable balloon 10 when used in combination with one or more first elongated bodies 720 .

FIGS. 36A-36F and 37A-37E show a first operating sequence of the detachable balloon catheter 1 with elastomeric tubular segment segment attachment system according to the embodiment shown in FIG. Elastomeric tubular segment 204 is joined in frictional contact 202 with the outside of first catheter 173 within proximal neck 130 of balloon 10 . Balloon 10 is positioned and expanded. The first catheter 173 can be separated from the proximal neck 130 of the balloon 10 by retracting the first catheter 173 with the elastomeric tubular segment 204 held in place by the third catheter 175 . Finally, the guidewire 40 is withdrawn.

FIGS. 38A-38J and 39A-39H illustrate a second operating sequence for the detachable balloon catheter 1 with elastomeric tubular segment 204 attachment system according to the embodiment shown in FIG. Elastomeric tubular segment 204 is joined in frictional contact 202 with the outside of first catheter 173 within proximal neck 130 of balloon 10 . Balloon 10 is positioned and inflated. Guidewire 40 is retracted. One or more coils or first elongated body 720 are positioned within the expanded balloon 10 . Once elastomeric tubular segment 204 is held in place by third catheter 175 , retraction of first catheter 173 can separate first catheter 173 from proximal neck 130 of balloon 10 .

FIGS. 40A-40K and 41A-41H illustrate a third operating sequence for the detachable balloon catheter 1 with elastic tubular segment 204 attachment system according to the embodiment shown in FIG. Elastomeric tubular segment 204 is joined in frictional contact 202 with the outside of first catheter 173 within balloon proximal neck 130 . Balloon 10 is positioned and inflated. Guidewire 40 is retracted. A coil or portion of the first elongated body 720 is positioned distal to the expanded balloon 10 . Second catheter 174 is partially retracted. The remaining portion of first elongated body 720 is disposed within expanded balloon 10 . Once the elastomeric tubular segment 204 is held in place by the third catheter 175, retraction of the first catheter 173 (with the second catheter 174) pulls the first catheter out of the proximal neck 130 of the balloon 10. 173 can be isolated.

The present disclosure relates to a medical device comprising a removable balloon 10 and a catheter or catheter assembly 5, wherein the removable balloon 10 is configured to separate from the catheter or catheter assembly 5 in vivo. In some embodiments, the balloon 10 is attached to the second catheter by a friction fit 202 provided by an elastomeric or resilient valve 192, as shown in FIGS. 44A-44B and 52A-52B. 174 are joined or operably connected. In some embodiments, the detachable balloon catheter 1 comprises a detachable assembly for joining the detachable balloon 10 to the second catheter 174, the detachable assembly being attached to the detachable balloon 10. With one or more elastomeric valves 192 joined to the distal neck 140 or distal neck assembly 142 , the one or more elastomeric valves 192 form a friction fit 202 with the distal portion of the second catheter 174 . configured to

In some embodiments, as shown in FIGS. 49A-49D, one or more elastomeric or elastic valves 192 include round punctures, slits along an axis, or orthogonal slits across two axes. It is in the shape of a disc with a central orifice, such as a central orifice or aperture. A central orifice or aperture through the entire thickness of valve 192 may be a slit resembling a plus or minus sign, or a round puncture. In some embodiments, one or more elastomeric valves 192 comprise polymers, silicones, polyurethanes or rubbers. In one embodiment, a single valve 192 is used that includes a silicone rubber disc of durometer ranging from about 40 Shore A to about 90 Shore A having a thickness of 0.010 inches and a round punctured central opening. In some embodiments, one or more washers or spacers are provided near 197 of one or more elastomeric valves 192, as shown in FIGS. 44A-44B, 50 and 52A-52B. , distal at 196, or both proximal and distal at 197 and 196. In some embodiments, proximal and distal spacers 197 and 196 are in the shape of discs with a central orifice, such as a central orifice containing a circular puncture, a slit along a diameter, or an orthogonal slit spanning two diameters. . In some embodiments, the proximal and distal spacers 197 and 196 may comprise elastomers or other elastic materials such as polymers including silicone, polyurethane or rubber. By way of example and not limitation, nominal dimensions and acceptable and preferred dimension ranges are shown in FIG. Presented in tabular form.

In some embodiments, one or more elastomeric or elastic valves 192 and proximal and distal spacers 197 and 196 are connected to the distal nosecone, as shown in FIGS. 44A-44B and 52A-52B. nosecone) 191. In some embodiments, the lumen or inner surface 193 of the distal nosecone 191 comprising one or more elastomeric valves 192, proximal spacers 197 and distal spacers 196 is formed by distal neck 140, distal neck assembly 142 or detachable. It is joined to the distal telescoping structure 185 of the possible balloon 10 . The nosecone 191 may include multiple valves 192 arranged in series with various combinations of central aperture geometry.

A mounting system comprising an elastomeric or elastic valve 192 in the distal nosecone 191 and an elastomeric tubular segment 204 integral with the proximal neck assembly 135 can be used alone as shown in FIGS. 45A-45F and 46A-46F. 47A-47J and 48A-48I, when used in combination with one or more first elongated bodies 720 disposed within balloon 10 as shown in FIGS. 40A-40K, 41A-41H, 47A-47J and 48A-48I. Structurally and functionally similar to that shown, it is adapted for deployment of the removable balloon 10 .

FIGS. 45A-45F and 46A-46E illustrate a first operational sequence of the mounting system comprising elastomeric or elastic valve 192 and elastomeric or elastic tubular segment 204 according to the embodiment shown in FIGS. Balloon 10 is positioned and expanded. With the elastomeric tubular segment 204 held in place by the third catheter 175 , the first catheter 173 (along with the second catheter 174 ) is retracted to remove the first catheter 173 from the proximal neck 130 of the balloon 10 . can be separated. Finally, retraction of guidewire 40 causes valve 192 to close.

FIGS. 47A-47J and 48A-48 illustrate a second operational sequence for a mounting system including elastomeric or elastic valve 192 and elastomeric or elastic tubular segment 204 according to the embodiment shown in FIGS. Balloon 10 is positioned and expanded. Guidewire 40 is retracted. Second catheter 174 is partially retracted, closing valve 192 . One or more coils or first elongated body 720 are positioned within the expanded balloon 10 . Retracting the first catheter 173 (together with the second catheter 174 ) by the elastomeric tubular segment 204 held in place by the third catheter 175 removes the first catheter from the proximal neck 130 of the balloon 10 . 173 can be isolated.

In some embodiments, the expanded detachable detachable balloon catheter 1 includes one or more elastomeric or elastic valves 192 joined to the distal neck 140 or distal neck assembly 142 of the detachable balloon 10 balloon 10 is inflated in artery 317, vein 318, LAA 800, aneurysm 320, body conduit 900 or other blood-containing or body space 904 and attached to at least a portion of the outer surface of balloon 10 or to balloon 10 A portion of the outer surface of expandable retention structure 731 contacts at least a portion of the wall of artery 317, vein 318, LAA 800, aneurysm 320, biological conduit 900 or other blood-containing or biological space 904. The second catheter 174 can then be separated from the expanded removable balloon 10 by pulling the second catheter 174 and the expanded removable balloon 10 apart.

In some embodiments, the detachable balloon 10 of the detachable balloon catheter 1 is expanded in an artery 317, vein 318, LAA 800, aneurysm 320, biological conduit 900 or other blood-containing or biological space 904, At least a portion of the outer surface of the expanded detachable balloon 10 or a portion of the outer surface of the expandable retention structure 731 attached to the balloon 10 are artery 317, vein 318, LAA 800, aneurysm 320, biological conduit 900. or other blood-containing space or at least a portion of the wall of the biological space 904, the second catheter 174 is expanded and removable by pulling the second catheter 174 and the expanded balloon 10 apart. can be separated from the balloon 10.

In some embodiments, the detachable balloon 10 of the detachable balloon catheter 1 is dilated in an artery 317, vein 318, LAA 800, aneurysm 320, biological conduit 900, or other blood-containing or biological space 904. , at least a portion of the outer surface of the expanded detachable balloon 10, or a portion of the outer surface of the expandable retention structure 731 attached to the balloon 10, may be an artery 317, a vein 318, an LAA 800, an aneurysm 320, a biological conduit. By pulling apart the assembly of second catheter 174, first catheter 173 and expanded balloon 10 when in contact with at least a portion of the wall of 900 or other blood-containing or biological space 904, the second The catheter 174 and first catheter 173 assemblies can be separated from the inflated removable balloon 10 .

In some embodiments, when the second catheter 174 is separated from the expanded removable balloon 10, the distal opening of the expanded removable balloon 10, the distal neck 140, the distal telescoping segment ( One or more elastomeric or resilient valves 192 are configured to close the distal telescoping segment 185 or distal neck assembly 142 . In some examples, one or more elastomeric or elastic valves 192 are placed in the central void 115 or the expanded removable balloon 10 following removal of the second catheter 174 from the expanded removable balloon 10 . configured to reduce blood flow through the interior volume of the

In some embodiments, the outer diameter of one or more elastomeric or resilient valves 192 is between 0.018 and 0.068 inches. With a valve 192 configured for a friction fit 202, the detachment process can be with or without a guidewire 40 extending through the valve 192 and terminating distal to the inflated removable balloon 10. Note that it can happen with It should also be noted that a coil or other elongated or expandable body 720 within lumen 162 of first catheter 173 or lumen 163 of second catheter 174 may be used to effect the separation process. Detachable balloons 10 of various sizes and shapes. Valve 192 may be used to attach removable balloons 10 of various sizes and shapes.

The present disclosure relates to a medical device comprising a removable balloon 10 and a catheter or catheter assembly 5, wherein the removable balloon 10 is configured to separate from the catheter or catheter assembly 5 in vivo. In some embodiments, the balloon is joined or operatively connected to the first catheter 173 by an electrolytically sensitive tubular structure, also called an “anode” 390 . In some embodiments, the removable balloon catheter 1 may comprise an electrolytic separation system including an anode 390 positioned between the first catheter 173 and the removable balloon 10.

An example of a removable balloon catheter 1 comprises an anode 390 with conductors extending from the hub or proximal end of a first catheter 173 electrically connecting with the anode 390 , the proximal end of anode 390 connecting to the first catheter 173 . and the distal end of anode 390 is joined to proximal neck 130 or proximal neck assembly 135 of balloon 10 . A current is passed through the conductor while anode 390 is immersed in the liquid containing the electrolyte for a time sufficient to cause at least partial dissolution of anode 390 and separation of the proximal and distal ends of anode 390. When flowing through the first catheter 173, the assembly of the first catheter 173, the proximal portion of the anode 390, the proximal neck 130 or the distal neck assembly 135 of the removable balloon 10, and The distal portion of anode 390 may be pulled away from the removable balloon.

In some embodiments, the adhesion between the first catheter 173 and the anode 390 is performed using an adhesive or glue, and the anode 390 and the proximal neck 130 or the proximal neck of the removable balloon 10 is attached. Adhesion to or from assembly 135 is accomplished using adhesives or glues or non-conductive or insulating adhesives or adhesives. In some embodiments, an adhesive or glue between anode 390 and proximal neck 130 or proximal neck assembly 135 of removable balloon 10 electrically isolates the balloon from anode 390 . In some embodiments, an adhesive or glue between first catheter 173 and anode 390 electrically isolates first catheter 173 from anode 390 . In some embodiments, the wall of anode 390 includes an inner layer that is more sensitive to electrolysis and an outer layer that defines an exterior surface that is less sensitive to electrolysis or corrosion. In some embodiments, the inner layer of anode 390 comprises stainless steel. In some embodiments, the outer layer of anode 390 that is not sensitive to electrolysis or corrosion comprises gold, silver, platinum, iridium, titanium, non-conductive polymers, non-conductive coatings, or alloys or combinations thereof. In some embodiments, the walls of the anode 390 are composed of an inner layer that defines an inner surface that is not sensitive to electrolysis or corrosion, an intermediate layer that is more sensitive to electrolysis or corrosion, and an outer layer that defines an outer surface that is not sensitive to electrolysis or corrosion. including. In some embodiments, the inner layer of anode 390 comprises gold, silver, platinum, iridium, titanium, non-conductive polymers, non-conductive coatings, or alloys or combinations thereof. In some embodiments, the outer layer of anode 390 comprises gold, silver, platinum, iridium, titanium, non-conductive polymers, non-conductive coatings, or alloys or combinations thereof. In some embodiments, the non-conducting polymer is parylene, polyurethane or silicone. In some embodiments, the intermediate layer of anode 390 comprises stainless steel, 300 series stainless steel, 400 series stainless steel, 302 stainless steel, 304 stainless steel, 316 stainless steel, 316L stainless steel, or 316LVM stainless steel. In some embodiments, at least a portion of the stainless steel portion of anode 390 is heat treated. In some embodiments, the outer layer of anode 390 is absent and the intermediate or stainless steel layer is exposed on the outer surface of the ring-shaped region of anode 390 . In some embodiments, the inner and outer layers of anode 390 are absent and the middle or stainless steel layer is exposed on the inner and outer surfaces of the ring-shaped region of anode 390 . In some embodiments, a stress concentration line or strip is formed in the ring-shaped area to allow a physician to destroy anode 390 in vivo. In some embodiments, the outer surface of the distal portion of first catheter 173 covers a portion of the inner surface of anode 390 to protect at least a portion of the inner surface of anode 390 from electrolysis or corrosion. In some embodiments, the inner surface of the distal portion of first catheter 173 covers a portion of the outer surface of anode 390 to protect at least a portion of the outer surface of anode 390 from electrolysis or corrosion. In some embodiments, the exterior surface of proximal neck 130 or proximal neck assembly 135 covers a portion of the interior surface of anode 390 to protect at least a portion of the interior surface of anode 390 from electrolysis or corrosion. In some embodiments, the inner surface of proximal neck 130 or proximal neck assembly 135 covers a portion of the outer surface of anode 390 to protect at least a portion of the outer surface of anode 390 from electrolysis or corrosion.

In some embodiments, the detachable balloon catheter 1 comprises an electrolytic detachment subsystem that includes an electrical circuit, part of which is supported by the first catheter 173 and the anode 390 detachment. , thereby causing separation of the expanded removable balloon 10 from the first catheter 173 . In some embodiments, at least a portion of the electrical circuit is supported on the first catheter 173 to cause electrolysis or corrosion in the ring-shaped region of the anode 390, and the portion of the anode 390 proximal to the ring-shaped region. It is configured to cause separation of the distal anode 390 portion of the ring-shaped region from the first catheter 173 thereby causing separation of the inflated balloon 10 from the first catheter 173 . In some embodiments, the electrolytic detachment subsystem places an anode in the region of the ring-shaped region of anode 390 to cause detachment of anode 390 so that the distal end of first catheter 173 can be detached from balloon 10 . configured to apply current in a manner forming 390; In some examples, the portion of anode 390 distal to the ring-shaped region is separated from the portion of anode 390 proximal to the ring-shaped region. In some embodiments, the electrolytic separation subsystem is configured to deliver a constant current of 1-10 mA, including delivery of current to anode 390 . In some embodiments, anode 390 is a ring-shaped region of anode 390 comprising stainless steel on the outer surface of the ring-shaped region.

In some embodiments, the outer surface of a ring structure, tubular structure, telescoping structure, catheter segment, or telescoping catheter segment is joined to the inner surface of the proximal neck 130 to form the proximal neck assembly 135 and the anode. 390 is glued or bonded to a ring structure, tubular structure, telescoping structure, catheter segment, or telescoping catheter segment. In some embodiments, the inner surface of the ring structure, tubular structure, telescoping structure, catheter segment, or telescoping catheter segment is adhered to the outer surface of the proximal neck 130 of the removable balloon 10 to form the proximal neck assembly. form 135; In some embodiments, the ring structure, tubular structure, telescoping structure, catheter segment, or telescoping catheter segment is made of metal, platinum, iridium, gold, silver, stainless steel, nitinol, titanium, or alloys thereof. Including combinations. In some embodiments, at least a portion of the ring structure, tubular structure, telescoping structure, catheter segment, or telescoping catheter segment is radiopaque and visible under fluoroscopy. , can assist the physician in confirming that the first catheter 173 has separated from the removable balloon 10 . In some embodiments, the inner surface of the ring structure, tubular structure, telescoping structure, catheter segment, or telescoping catheter segment 190 is adhered to the outer surface of the proximal neck 130 of the removable balloon 10 and the proximal neck An assembly 135 is formed. In some embodiments, the ring structure, tubular structure, telescoping structure, catheter segment, or telescoping catheter segment is made of metal, platinum, iridium, gold, silver, stainless steel, nitinol, titanium, or alloys thereof. Including combinations. In some embodiments, at least a portion of the ring structure, tubular structure, telescoping structure, catheter segment, or telescoping catheter segment is radiopaque and visible under fluoroscopy. , can assist the physician in confirming that the first catheter 173 has separated from the removable balloon. In some embodiments, tubular or ring-like structure 185 resides in the wall of the distal portion of first catheter 173 . In some embodiments, the tubular or ring-like structure 190 present in the wall of the distal portion of the first catheter is made of metal, platinum, iridium, gold, silver, stainless steel, nitinol, titanium, or alloys or Including combinations thereof. In some embodiments, at least a portion of the tubular or ring-like structure 190 present in the wall of the distal portion of the first catheter 173 is radiopaque and visible under fluoroscopy. It is possible and can assist the physician in confirming that the first catheter 173 has separated from the removable balloon. In some embodiments, a tubular or ring-like structure 190 resides in the wall of the distal portion of the first catheter 173, and in other embodiments, the tubular or ring-like structure 190 is located on the first catheter 173. is adhered or bonded to the outer surface of the distal portion of the

In some embodiments, the detachable balloon catheter 1 further includes conductors extending from the hub or proximal end of the first catheter 173 and making electrical connections with the cathode tubular structure 405 . In some embodiments, at least a portion of the one or more conductors are embedded in the wall of the first catheter 173 to serve as electrical conductors for the electrolytic separation subsystem and provide structural reinforcement to the wall of the first catheter 173. I will provide a. In some embodiments, at least a portion of the conductor is routed through the wall of first catheter 173 in a spiral, coiled, braided, or straight configuration. In some embodiments, the one or more conductors are wires or copper wires with an electrically insulating polymer coating. In some embodiments, the electrolytic separation subsystem is configured to deliver a constant current to anode 390 . In some embodiments, proximal hub 179 of first catheter 173 includes an electrical jack to which the proximal end of the lead connected to anode 390 is connected. In some embodiments, the proximal hub 179 of the first catheter 173 comprises an electrical jack to which the proximal end of the conductor wire connected to the cathode tubular structure 405 on the first catheter is connected. be.

In some examples, after electrolysis or corrosion of a portion of the anode 390, the assembly of the distal portion of the anode 390, the removable balloon proximal neck 130 or proximal neck assembly 135, and the expanded removable A flexible balloon is assembled with the proximal portion of the anode 390 and the first catheter 173 by pulling on the first catheter 173 while the inflated removable balloon 10 remains fixed in place. can be separated from In some examples, after electrolysis or corrosion of a portion of the anode 390, the assembly of the distal portion of the anode 390, the proximal neck 130 or proximal neck assembly 135 of the removable balloon 10, and the expanded detachment. The flexible balloon is moved proximally of the anode 390, the first catheter 173 by pulling on the first and second catheters 173 and 174 while the inflated removable balloon 10 remains fixed in place. , and the second catheter 174 assembly. In some examples, the inflated removable balloon 10 is attached to the wall of a saccular aneurysm 320, artery 317, vein 318, LAA 800, other blood-containing structure, conduit 900 or biological space 904. Once mated, the first catheter 173 assembly and removable balloon 10 assembly are pulled apart.

By way of example and not limitation, nominal dimensions and acceptable preferred dimension ranges for various potential embodiments of the anodes described in FIGS. 55A-55E and 57A-57D are presented in tabular form in FIG. In some embodiments, the inner diameter or lumen diameter of the anode is 0.025 to 0.068 inches. In some embodiments, the outer diameter of the anode is 0.029 to 0.072 inches.

At the anode 390, the separation process extends through the central void 115 of the expanded removable balloon, with or without the guidewire 40 terminating distally of the expanded removable balloon. Note that this can also happen. Also note that the separation process may occur with a coil or other elongated or expandable body 10 within lumen 162 of first catheter 173 or lumen 163 of second catheter 174 . Anode 390 may be used to attach removable balloons 10 of various sizes and shapes.

The electrolytic separation system including anode 390, when used alone as shown in FIGS. 1 when used in combination with one or more elongated bodies 720 positioned or positioned both within and distal to balloon 10 as shown in FIGS. 62A-62I and 63A-63I. Adapted for deployment of removable balloon 10 when used in combination with one or more elongated bodies 720 .

58A-58E and 59A-59E illustrate a first operational sequence of the electrolytic separation system according to the embodiment illustrated in FIGS. 55 and 57. FIG. Balloon 10 is positioned and expanded. Electrolytic separation controller 406 is connected by cable 407 to hub 179 of first catheter 173 and balloon 10 is electrolytically separated. Finally, guidewire 40, first catheter 173, and second catheter 174 are simultaneously withdrawn.

60A-60I and 61A-61H illustrate a second operational sequence of the electrolytic separation system according to the embodiment illustrated in FIGS. 55 and 57. FIG. Balloon 10 is positioned and expanded. Guidewire 40 is retracted. The second catheter 174 is partially retracted and one or more coils or first expandable body 720 is positioned within the expanded balloon 10 . Electrolytic separation controller 406 is connected by cable 407 to hub 179 of first catheter 173 and balloon 10 is electrolytically separated. Finally, guidewire 40, first catheter 173 and second catheter 174 are simultaneously withdrawn.

62A-62I and 63A-63I illustrate a third operational sequence of the electrolytic separation system according to the embodiment illustrated in FIGS. 55 and 57. FIG. Balloon 10 is positioned and expanded. Guidewire 40 is retracted. A coil or portion of the first expandable body 720 is positioned distal to the expanded balloon 10 . The second catheter 174 is partially retracted and the remaining portion of the first expandable body 720 is positioned within the expanded balloon 10 . Electrolytic separation controller 406 is connected by cable 407 to hub 179 of first catheter 173 and balloon 10 is electrolytically separated. Finally, guidewire 40, first catheter 173 and second catheter 174 are simultaneously withdrawn.

In one embodiment, stainless steel (SST) rings are attached to the proximal neck 130 of the removable balloon 10 and the first catheter 173, as shown in FIGS. 55A-55E and 57A-57D. . The SST ring 224 may be constructed from any biocompatible stainless steel alloy including, but not limited to, 300 series stainless steel or 400 series stainless steel, preferably 304, 316, 316L or 316LVM stainless steel. In another embodiment, a stainless steel (SST) ring 224 is attached to proximal neck 130 by welding or gluing after formation of removable balloon 10 . In other embodiments, the neck 215 may be constructed of stainless steel and may be incorporated during formation of the removable balloon 10, or may be subsequently welded or glued to the body. The SST ring 224 or SST neck 215 is constructed from any biocompatible stainless steel alloy including, but not limited to, 300 series stainless steel or 400 series stainless steel, preferably 304, 316, 316L or 316LVM stainless steel. good too. In various embodiments, SST ring 224 includes an insulating coating. Insulative coating 226 may be any biocompatible polymeric coating. In one aspect, insulating coating 226 is a dielectric material. A portion of the polymer coating is removed from the outer surface of ring 224 to expose a metal surface that may have a strip or ring 228 configuration. In other embodiments, an exposed metal surface can be formed by masking this area of ring 228 prior to applying the coating and then removing the masking material. When the desired current is applied, electrolysis occurs and cuts the uncoated metal strip, thereby separating the expanded removable balloon 10 from the first catheter 173 . The metal strip may be exposed by any suitable method including, but not limited to laser etching or laser ablation. In other embodiments, the metal strip at the separation site may be exposed before or after folding or compressing the removable balloon 10 . By way of example and not limitation, in one embodiment the exposed metal in the region may be gold plated, and in another embodiment the exposed metal is stainless steel. In one embodiment, the neck 215 or ring 224 has an average wall thickness of 23 μm±5 μm, and the laser-etched isolation has an average wall thickness of about 15 μm, a width of about 125 μm, and a width of about 125 μm from the end of the neck 215 . located at 1 mm. In this embodiment, the laser etched portion is subsequently masked during the electroforming process. The width W of the separation site (ie, the exposed metal surface of the strip or ring configuration) may range from about 0.1 mm to about 0.4 mm. The separation site may be located anywhere along the length N1 of the neck. In some embodiments, W may be located in the area of neck 215 formed by metal ring 224 . In one particular embodiment, the exposed strip of separation site has a width W of 0.25 mm±0.03 mm and is located approximately 0.51 mm±0.03 mm from the end of the neck.

The present disclosure relates to a medical device comprising a removable balloon 10 and a catheter or catheter assembly 5, wherein the removable balloon 10 is configured to separate from the catheter or catheter assembly 5 in vivo. In some embodiments, the balloon 10 is positioned over the first catheter 173 by a heat sensitive tubular structure 204 or a tubular structure that is solid at body temperature but melts above body temperature with the application of heat. coupled or operably coupled to

In some embodiments, the detachable balloon catheter 1 comprises a removable assembly for coupling the detachable balloon to the first catheter 173, wherein the detachable assembly is heated at a temperature of 50°C to 100°C. a heat sensitive tubular structure containing a material that melts at In some examples, when the heat sensitive tubular structure is warmed to a temperature above its melting point for a time sufficient to cause at least a portion of the heat sensitive tubular structure to melt and the heat sensitive tubular structure to separate, the heat sensitive The distal portion of the tubular structure, the proximal neck 130 or proximal neck assembly 135 of the removable balloon 10 and the expanded removable balloon assembly are assembled so that the expanded removable balloon 10 is in place. By pulling on the first catheter 173 while it is stationary, it can be separated from the assembly of the proximal portion of the heat sensitive tubular structure and the first catheter 173 . In some examples, the temperature at which the heat sensitive tubular structure exceeds its melting point for a time sufficient to cause melting of at least a portion of the heat sensitive tubular structure and separation of the heat sensitive tubular structure. , the distal portion of the heat-sensitive tubular structure, the proximal neck 130 or proximal neck assembly 135 of the removable balloon 10, and the expanded removable balloon assembly transform into the expanded removable balloon. From the assembly of the proximal portion of heat sensitive tubular structure 410, first catheter 173 and second catheter 174, by pulling on first and second catheters 173 and 174 while 10 remains fixed in place. can be separated. In some examples, the expanded removable balloon 10 engages the walls of a saccular aneurysm 320, artery 317, vein 318, LAA 800, other blood-containing structure, biological conduit 900, or biological space 904. Once mated, the first catheter 173 assembly and removable balloon 10 assembly are pulled apart.

In some embodiments, the heat sensitive tubular structure comprises polymer segments. In some embodiments, the proximal end of the heat sensitive tubular structure is glued to the distal end of the first catheter 173 and the distal end of the heat sensitive tubular structure 410 is near the removable balloon 10 . It is glued to the proximal neck 130 or proximal neck assembly 135 . In some embodiments, the distal end of first catheter 173 is bonded or adhered to the heat sensitive tubular structure using glue or adhesive. In some embodiments, the distal end of the heat sensitive tubular structure and the proximal neck 130 or proximal neck assembly 135 of the removable balloon 10 are bonded or adhered using a glue or adhesive. In some embodiments, the distal end of the first catheter 173 is bonded or glued to the heat sensitive tubular structure 410 , the distal end of the heat sensitive tubular structure 410 and the proximal end of the removable balloon 10 . Neck 130 or proximal neck assembly 135 are bonded or adhered using glue or adhesive.

In some embodiments, the heat sensitive tubular structure comprises material forming at least a portion of the distal end of first catheter 173 . In some embodiments, the distal end of the heat sensitive tubular structure portion 411 of the first catheter 173 and the neck 130 or proximal neck assembly 135 of the removable balloon 10 are secured using glue or adhesive. bonded or glued together.

In some embodiments, the heat sensitive tubular structure is a material that forms a bond 409 between the distal end of the first catheter 173 and the proximal neck 130 or proximal neck assembly 135 of the removable balloon 10. , the first catheter 173 can be separated from the removable balloon 10 when at least a portion of the heat sensitive bond 409 melts.

In some embodiments, the detachable balloon catheter 1 comprises an electrothermal isolation subsystem with an electrical circuit, part of the electrical circuit supported on the first catheter 173 and the heat sensitive tubular structure. It is configured to provide energy to the heat sensitive tubular structure in a manner that raises at least a portion to a temperature of 50°C to 100°C. In some embodiments, the electrothermal isolation subsystem includes an electrical circuit, at least a portion of the first circuit is supported on the first catheter 173, the electrical circuit includes a resistive heating element, the electrothermal isolation subsystem is configured to deliver current to the resistive heating element. In some embodiments, when a current is passed through the resistive heating element, the resistive heating element warms to a temperature between 50°C and 100°C. In some examples, when the resistive heating element warms to a temperature of 50°C to 100°C, at least a portion of the heat sensitive tubular structure warms to a temperature of 50°C to 100°C. In some embodiments, the resistive heating element comprises wire, wire comprising nickel, chromium, iron, aluminum, copper or combinations thereof, Nichrome wire, Kanthal wire, Constantan wire ( constantan wire, Evanohm wire, Balco wire, Cupron wire or Manganin wire. In some embodiments, at least or a portion of the resistive heating element or wire is positioned adjacent to the heat sensitive tubular structure. In some embodiments, the electrothermal isolation subsystem includes one or more conductors, including conductors that are wires or insulated wires. In some embodiments, at least a portion of the one or more conductors are embedded in the wall of the first catheter 173 for structural reinforcement of the conductors of the first electrothermal isolation subsystem and the wall of the first catheter 173. works as both. In some embodiments, the conductor passes through at least a portion of the wall of first catheter 173 in a spiral, coiled, braided, or straight configuration. In some embodiments, the electrothermal isolation subsystem is configured to deliver a constant current or constant voltage to the resistive heating element or wire.

In some embodiments, the third medical device 1 includes an electrothermal isolation subsystem for use with a detachable balloon catheter 1 that includes a heat sensitive tubular structure. In some embodiments, the third medical device 1 includes an electrical circuit, a portion of the electrical circuit supported by the third medical instrument 412, and the distal portion of the third medical device 412 from 50°C. It is configured to deliver energy to the distal portion of the third medical device 412 in a manner that raises the temperature to between 100°C. In some embodiments, the third medical device 412 includes an electrical circuit, at least a portion of the electrical circuit is supported on the third medical device 412, the electrical circuit comprises a resistive heating element, and the third Medical device 412 is configured to deliver electrical current to the resistive heating element. In some embodiments, the electrothermal isolation subsystem of the third medical device 412 delivers current to the resistive heating element in a manner that raises the temperature of the resistive heating element to a temperature between 50°C and 100°C. Configured. In some examples, the first medical device 1 is configured such that the third medical device 412 is inserted into the lumen 162 of the first catheter 173 of the first medical device 1 and the resistive heating element of the third medical device 412 and placed in or adjacent to the heat sensitive tubular structure 410 of the first medical device 1 that melts at a temperature between 50°C and 100°C, the temperature of the resistive heating element being between 50°C and 100°C. At least a portion of the heat sensitive tubular structure 410 of the first medical device 1 melts when current is passed through the resistive heating element of the third medical device 412 in a manner that raises the temperature to between The first catheter 173 of one medical device 1 is configured to be separable from the proximal neck 130 or proximal neck assembly 135 of the removable balloon 10 of the first medical device 1 . In some embodiments, the outer diameter of the portion of the third medical device 1 that warms to a temperature between 50° C. and 100° C. 0.001, 0.002, 0.003, 0.004, 0.005, 0.006, 0.007, 0.008, 0.009 or 0.010 inches less than the inner diameter of one catheter 173 . In some embodiments, the resistive heating element of the third medical device 1 comprises wire, wire comprising nickel, chromium, iron, aluminum, copper or combinations thereof, Nichrome wire, Kanthal wire ( Kanthal wire, Constantan wire, Evanohm wire, Balco wire, Cupron wire or Manganin wire. In some embodiments, the resistive heating element or wire is placed on the outer surface of the third medical device 1 or the outer surface of the catheter of the third medical device 412 . In some embodiments, the third medical device 412 includes one or more second conductors, and at least a portion of the one or more second conductors is a wall of the third medical device 412 or a third conductor. and serves as both an electrical conductor and structural reinforcement for the second electrothermal isolation subsystem for the wall of the third medical device 412 or the catheter of the third medical device 412. do. In some embodiments, at least a portion of the conductors of the third medical device 412 spirally, coiled, braided or straight through the wall of the third medical device 412 or the catheter of the third medical device 412. passed in the form. In some embodiments, the conductor of third medical device 412 is a wire. In some embodiments, the electrothermal isolation subsystem of the third medical device 412 is configured to deliver constant current or constant voltage to resistive heating elements or wires of the third medical device 412 .

In some examples, after melting a portion of the heat sensitive tubular structure, the assembly of the distal portion of the heat sensitive tubular structure, the proximal neck 130 or proximal neck assembly 135 of the removable balloon 10, and the expanded The detachable balloon is assembled by pulling on the first catheter 173 with the inflated detachable balloon 10 fixed in place to assemble the proximal portion of the heat sensitive tubular structure and the first catheter 173 . can be separated from In some examples, when a portion of the heat sensitive tubular structure 410 melts, the distal portion of the heat sensitive tubular structure 410, the proximal neck 130 or proximal neck assembly 135 of the removable balloon 10, and the expanded Assembly of the removable balloon 10 is performed by pulling on the first and second catheters 173 and 174 while keeping the expanded removable balloon 10 fixed in place, thereby removing the proximal portion of the heat sensitive tubular structure 410 . , first catheter 173 , and second catheter 174 assembly. In some examples, the inflated removable balloon 10 engages the walls of a saccular aneurysm 320 , artery 317 , vein 318 , LAA 800 , other blood-containing structures, biological conduit 900 , or biological space 904 . Once mated, the first catheter 173 assembly and removable balloon 10 assembly are pulled apart.

In a heat-sensitive tubular structure, the separation process is with or without the guidewire 40 extending through the central void 115 of the expanded removable balloon and terminating distally of the expanded removable balloon. Note that it can occur in nonexistent states. It should also be noted that the separation process may occur in a coil or other elongated or expandable body 10 within the lumen of first catheter 173 or second catheter 174 . The heat sensitive tubular structure may be used for mounting removable balloons of various sizes and shapes.

The heat sensitive tubular structure 410 , the heat sensitive distal portion 411 of the first catheter 173 , or the heat sensitive coupling between the distal end of the first catheter 173 and the proximal neck 130 of the removable balloon 10 . 73A-73F and 74A-74E, the balloon 10 as shown in FIGS. 75A-75I and 76A-K when used alone as shown in FIGS. When used in combination with one or more elongated bodies 720 disposed within or disposed both within and distal to balloon 10 as shown in FIGS. It is adapted for deployment of balloon 10 when used in combination with one or more elongated bodies 720 .

73A-73F and 74A-74E illustrate a first operational sequence of the electrothermal separation system according to the embodiment illustrated in FIGS. 64 and 65. FIG. Balloon 10 is positioned and expanded. Guidewire 40 and second catheter 174 are retracted and replaced with heated catheter 412 . Electrothermal detachment controller 406 is connected by cable 407 to heating catheter 412 and balloon 10 is detached by melting heat-sensitive first tubular structure 410 . Finally, first catheter 173 and heating catheter 412 are retracted simultaneously.

75A-75I and 76A-76K illustrate a second operational sequence of the electrothermal separation system according to the embodiment illustrated in FIGS. 64 and 65. FIG. Balloon 10 is positioned and expanded. Guide wire 40 is retracted. The second catheter 174 is partially retracted and one or more coils or expandable bodies 720 are positioned within the expanded balloon 10 . Guidewire 40 and second catheter 174 are retracted and replaced with heated catheter 412 . Electrothermal detachment controller 406 is connected to heating catheter 412 by cable 407 and balloon 10 is detached by melting heat sensitive first tubular structure 410 . Finally, the first catheter 173 and the heating catheter 412 are retracted simultaneously.

77A-77I and 78A-78K illustrate a third operational sequence of the electrothermal separation system according to the embodiment illustrated in FIGS. 64 and 65. FIG. Balloon 10 is positioned and expanded. Guide wire 40 is retracted. A portion of the coil or elongated body 720 is positioned distal to the expanded balloon 10 . Second catheter 174 is partially retracted and the remainder of elongated body 720 is positioned within expanded balloon 10 . Guidewire 40 and second catheter 174 are retracted and replaced with heated catheter 412 . Electrothermal detachment controller 406 is connected by cable 407 to heating catheter 412 and balloon 10 is detached by melting heat sensitive first tubular structure 410 . First catheter 173 and heating catheter 412 are retracted simultaneously.

In one embodiment, a resistance wire 400 is incorporated into a third medical device 1 coaxial with and internal to the first catheter 173 . A heat sensitive coupling 410 couples the proximal neck 130 of the removable balloon 10 to the first catheter 173 . In one aspect, the heat sensitive coupling 410 is a tubular structure that is attached or glued to the removable balloon at one end and to the first catheter 173 at the other end. In another aspect, the heat sensitive coupling is the heat sensitive distal end 411 of the first catheter 173, which is affixed to the proximal neck 130 or proximal neck assembly 135 of the removable balloon 10. attached or glued. In another aspect, the heat sensitive coupling is a heat sensitive coupling 409 between the first catheter 173 and the proximal neck 130 or proximal neck assembly 135 of the removable balloon 10 . The second catheter 174 remains within the first catheter 173 during deployment of the removable balloon and one or more elongated bodies or coils 720 . After expansion of removable balloon 10 and placement of one or more elongated bodies or coils 720 at one or more desired locations, second catheter 174 is replaced with third medical device 412 . At its distal tip, a third medical device 412 is electrically coupled to a marker band 612 and a pair of conductive wires 402 embedded within the catheter and extending to its proximal end for connection to an isolation controller 406 . It features both mating resistance wire 400 segments. Current is applied through conductive wire 402 and resistive wire 400 using isolation controller 406 . The applied current heats the segment of resistive wire 400 and the nearby heat sensitive tubular structure 410 to a temperature in the range of about 40° C. to about 95° C., melting the heat sensitive couplings 409, 410 or 411 to form the first sufficient to separate the inflated removable balloon 10 from the catheter 173 . Optionally, distal neck 140 of detachable balloon 10 may be retained at distal end 194 of second catheter 174 by valve 192 mounted within distal nosecone 191 . This valve 191 closes the distal neck 140 of the removable balloon 10 when the second catheter 174 is removed, blocking blood flow through the central void 115 or the interior volume of the expanded, detached balloon 10 . do.

In another embodiment, a segment of resistance wire 400 is adjacent to the heat sensitive coupling between first catheter 173 and proximal neck 130 or proximal neck assembly 135 of removable balloon 10, or Incorporated, resistance wire segment 400 is either embedded within the wall of first catheter 173 or placed within first lumen 162 of detachable balloon catheter 1 and is routed to isolation controller 406 using cable 407 . is electrically engaged with a pair of conductive wires 402 that extend to the proximal end of the removable balloon catheter 1 for connection to the .

In one embodiment, shown in FIGS. 64A-64D and 65A-65D, the heat sensitive coupling is a heat sensitive tubular structure 410 with one end affixed or glued to the removable balloon and the other end 1 is a heat sensitive tubular structure 410 that is attached or glued to the catheter 173 . By way of example and not limitation, nominal dimensions for various potential embodiments of the heat sensitive tubular structure 410 described in FIGS. 65A-65D and acceptable and preferred dimension ranges are tabulated in FIG. In some embodiments, the inner diameter or lumen diameter of heat sensitive tubular structure 410 is between 0.025 and 0.078 inches. In some embodiments, the outer diameter of heat sensitive tubular structure 410 is between 0.027 and 0.080 inches.

In another embodiment, shown in FIGS. 67A-67D and 68A-68D, a heat sensitive coupling is incorporated into the distal end of first catheter 173, which is proximal to removable balloon 10. Affixed or glued to proximal neck 130 or proximal neck assembly 135 . By way of example and not limitation, nominal dimensions for various potential embodiments of the heat-sensitive distal end of first catheter 173 described in FIGS. indicated by

In another embodiment, shown in FIGS. 70A-70D and 71A-71C, heat-sensitive coupling 410 connects first catheter 173 and proximal neck 130 or proximal neck assembly 135 of detachable balloon 10. is a bond between The dimensions of various potential embodiments of the heat-sensitive coupling to the first catheter 173 described in FIGS. 71A-71C and the acceptable preferred ranges of dimensions are tabulated in FIG.

After deployment of the removable balloon 10 and optionally one or more elongated bodies or coils, the second catheter 174 can be removed or left within the first catheter 173 . A current is passed through the conductive wire 402 and the resistive wire 400 . The applied electrical current heats the segment of resistive wire 400 and the nearby heat sensitive coupling 410 to a temperature in the range of about 40° C. to about 95° C., melting the heat sensitive coupling 410 and extending it out of the first catheter 173 . sufficient to separate the removable balloons 10 from each other. Optionally, distal neck 140 of detachable balloon 10 may be retained at distal end 194 of second catheter 174 by valve 192 mounted within distal nosecone 191 . This valve 192 closes the distal neck 140 of the removable balloon 10 when the second catheter 174 is removed, blocking blood flow through the central void 115 or the interior volume of the expanded, detached balloon 10 . do.
Fully Detachable Balloon Catheter or First Medical Device

Medical device 1 including a removable balloon may further comprise a first catheter 173 coupled to the proximal end of removable balloon 10 . In some embodiments, the first catheter is connected to proximal neck 130 of removable balloon 10 . In some embodiments, first catheter 173 is coupled to removable balloon 10 by friction fit 202 . In some embodiments, the first catheter 173 is attached to the removable balloon 10 by glue, adhesive, solder or welding.

The medical device 1 with removable balloon may further comprise a second catheter 174 that passes through the central cavity 115 of the removable balloon and couples with the distal end or distal neck 140 of the removable balloon. . In some embodiments, the second catheter 174 is attached to the removable balloon by a friction fit through an elastomeric or elastic valve 192, including an elastomeric or elastic valve 192 that is part of the distal nosecone 191 assembly. Combined. In some embodiments, the tip of second catheter 174 is visible under fluoroscopy to aid in delivery and separation of the expandable body from first elongated body 720 or second elongated body 721. Further includes one or two marker bands 612 configured.

In some embodiments of the medical device comprising the removable balloon 10, the tip of the second catheter 174 is moveable into the biological space 904 adjacent or distal to the expanded removable balloon 10. can proceed. As used herein, to mobilize the second catheter 174 is to operate the control mechanism of its proximal hub 178 or the hemostasis valve of the Tuohy Borst adapter 186 on the first catheter 173. to reduce friction between the hemostasis valve and the outer surface of the adjacent second catheter 174, which secures the removable balloon 10 and the rest of the first catheter 173. The assembled assembly is advanced into the distal biological space 904 and steered or guided to the desired location. The second catheter 174 may also be movable and navigable by other suitable means including, but not limited to, mechanical placement, magnetic interaction, or use of electrical current, among others.

In some embodiments of the medical device 1 comprising a removable balloon 10, the tip of the second catheter 174 can be advanced into the body space distal to the removable balloon 10 when expanded. . One or more first elongated bodies 720 or expandable bodies pass through the lumen 163 of the second catheter 174 to the expanded balloon 10 prior to separating the first catheter 173 from the removable balloon 10 . It can be placed in adjacent biological space 904 . As such, the second catheter 174 may also be referred to as a "coiling catheter." In some embodiments of medical device 1 with removable balloon 10 , the tip of second catheter 174 can be pulled back into central void 115 of removable balloon 10 upon expansion. One or more first elongated bodies 720 or expandable bodies pass through lumen 163 of second catheter 174 to detachable balloon 10 prior to separating first catheter 173 from detachable balloon 10 . It can be located in the central cavity 115 . One or more first elongated or expandable bodies 720 are positioned through the lumen 163 of the second catheter 174 into the remainder of the lumen 322 of the aneurysm 320 not filled with the expanded balloon 10 . obtain. The tip of the second catheter 174 can be repositioned into the remaining portion of the lumen 322 of the aneurysm 320 not filled with the expanded balloon 10, followed by one or more additional first elongate bodies. Alternatively, an expandable body 720 or medical device can be deployed. The tip of the second catheter 174 can be repositioned into the remaining portion of the lumen 322 of the aneurysm 320 that is not filled with the expanded balloon 10, followed by one or more additional first elongated elongated catheters. A body or expandable body 720 or medical device can be deployed. The first and second catheter 173 and 174 assemblies can be separated or detached from the expanded balloon 10 and the first and second catheters 173 and 174 can be removed. Manipulation of components at the hub may cause advancement or retraction of the second catheter 174 relative to the expanded balloon 10, the first catheter 173 or the third catheter 175. FIG. The second catheter 174 is movably and forwardly advanced relative to the inflated balloon 10 , the first catheter 173 or the third catheter 175 to uncover the aneurysm 320 behind the inflated balloon 10 . Placement of one or more first elongated or expandable bodies 720 or medical devices into filling lumen 322 can be facilitated. The second catheter 174 further includes one or more radiopaque marker bands 612 to help identify the catheter tip location using fluoroscopy, and a first elongated or expandable body 720. Or it may help facilitate placement and separation of a medical device placed through lumen 163 of second catheter 174 .

In some embodiments, a ring structure, tubular structure, telescoping structure, catheter segment or telescoping catheter segment 185 is adhered to the distal neck 140 of the removable balloon and is removable from the outer surface of the second catheter 174 . It helps form a tight seal with the distal neck 140 or neck assembly of the removable balloon 10, facilitates expansion of the removable balloon 10, or provides a second Facilitates sliding of distal neck 140 of removable balloon 10 over catheter 174 . During expansion of the detachable balloon 10 , the ring structure, tubular structure, telescoping structure, catheter segment or telescoping catheter structure 185 allows the body of the detachable balloon 10 to shorten axially 706 . In the case of a medical device 1 comprising a removable balloon 10 intended for use in the treatment of a saccular aneurysm 320, this would result in a separation of the distal end of the expanded removable balloon 10 and the dome of the aneurysm 320. The distance between first elongated body 720 or expandable body 10 is maximized to minimize the risk of injuring, rupturing or puncturing the often fragile dome of aneurysm 320. , may be placed in the sac or lumen of the aneurysm 322 distal to the inflated removable balloon 10 . The ring structure, tubular structure, telescoping structure, catheter segment or telescoping catheter segment 185 also reduces leakage of the injected fluid medium from the removable balloon during inflation, reduces the pressure required for inflation, The disintegration rate of detachable polymer balloons and detachable flexible metallized polymer balloons 14 after expansion in vivo may be reduced. In some embodiments, the ring, tubular or nested structures 185 are gold, platinum, iridium, tantalum, or combinations or alloys thereof that can also serve as radiopaque markers visible under fluoroscopy. It may be a section of metal tube containing In one aspect, the radiopaque ring structure, tubular structure or nested structure enhances the visibility of the removable balloon 10 under fluoroscopic imaging. In another aspect, the radiopaque ring structure, tubular structure or telescoping structure 185 may be formed by a physician prior to placing all or a portion of first elongated body 720 or expandable body 10 in vivo. It may assist in positioning the tip of the second catheter 174 , including placement within or adjacent to the central void 115 of the inflated removable balloon 10 . Alternatively, the ring structure, tubular structure, telescoping structure, catheter segment or telescoping catheter segment 185 may be constructed of a polymer and include radiopaque marker spots or bands 612 for removable balloon under fluoroscopic imaging. 10 visibility can be enhanced. In another aspect, radiopaque marker spots or bands 612 or ring structures, tubular structures, or telescoping structures 185 may be used to extend all or part of first elongated body 720 or expandable body 10 in vivo. Prior to deployment, the physician may assist in positioning the tip of the second catheter 174, including placement within or adjacent to the central cavity 115 of the expanded removable balloon 10.
Fabrication of Detachable Balloon Catheters - Fabrication of Detachable Polymer Balloons and Detachable Metallized Polymer Balloons

The method of manufacturing the first medical device 1 disclosed herein comprises a removable polymer balloon 12, a removable metallized polymer balloon 14, a removable flexible metallized polymer balloon, a removable Included are methods of making rigid metallized polymer balloons, removable metal balloons 16 and removable polymer coated metal balloons 18 .

In one embodiment, the first medical device 1 is made by manufacturing a first catheter 173, manufacturing a second catheter 174, manufacturing a detachable polymeric balloon 12 having proximal and distal openings, which making the first polymer layer 99 of the removable polymer balloon 12 continuous except for the proximal and distal openings, pleating the walls 30 of the removable polymer balloon 12 by The pleated collapsible removable polymeric balloon is placed in a first position in a manner that permits separation of the removable polymeric balloon 12 from the first catheter 173 after being formed in a folded configuration and expanded within the patient. Coupled or operably connected to catheter 173 . In another example, the expanded removable metallized polymer balloon 14 is placed on the first catheter 173 in a manner that allows separation of the removable metallized polymer balloon 14 from the first catheter 173 after expansion into the patient. The wall 30 of the removable metallized polymer balloon 14 is formed into a pleated, folded configuration. The polymer layer 99 is continuous except for the proximal and distal openings, and the removable balloon 10 without the metal layer 90 is labeled "removable polymer balloon", "polymer balloon", "removable polymer only". balloons” or “polymer-only balloons” 12 .

In some embodiments, polymer layer 99 of removable polymer balloon 12 comprises PET, Nylon or Pebax. In some embodiments, removable polymer balloon 12 is manufactured by blow molding. In some embodiments, the removable polymeric balloon 12 has a distal region 120, a proximal region 110 generally opposite the distal region 120, and an intermediate region 100 transitioning from the distal region 120 to the proximal region 110. , in other embodiments, the removable polymeric balloon 12 is formed with a distal region 120 and a proximal region 110 without the intermediate region 100 . In some embodiments, the detachable polymeric balloon 12 has a rated burst pressure of 1 to 30 atmospheres. In some embodiments, the wall 30 of the removable polymer balloon 12 has a thickness of 5-75 μm. In some embodiments, at least a portion of the outer surface of removable polymeric balloon 12 includes a textured surface. In some embodiments, at least a portion of the outer surface of the removable polymer balloon 12 comprises a textured surface, between the highest portion of the outer surface of the removable balloon 10 and the lowest portion of the outer surface of the removable polymer 10. The distance of is 0.0001 to 1 μm.

In one embodiment, the first medical device 1 is made by manufacturing a first catheter 173, manufacturing a second catheter 174, manufacturing a removable polymer balloon 12 having proximal and distal openings, Thereby making the first polymer layer 99 of the removable polymer balloon 12 continuous, except for the proximal and distal openings, and expanding the removable polymer balloon 12 to a thickness in the range of 0.0005 to 1 μm. adding a thickness of a first metal layer 90 to at least a portion of the outer surface of the removable polymer balloon 12 through a sputter coating or vapor deposition process to pleat the walls 30 of the removable metallized polymer balloon 14; A collapsible removable polymeric balloon that is formed into a folded configuration and pleated in a manner that allows separation of the removable metallized polymeric balloon 14 from the first catheter 173 after expansion into the patient. 14 is coupled or operably connected to the first catheter 173 . In another example, the expanded detachable metallized polymer balloon 14 is expanded within the patient in a manner that allows separation of the detachable metallized polymer balloon 14 from the first catheter 173 after expansion. After being bonded or operatively connected to the catheter 173, the wall 30 of the removable metallized balloon 14 is pleated and formed into a folded configuration. Removable metallized polymer balloons 14 without structural metal layer 90 are also referred to as "flexible metallized polymer balloons" or "removable flexible metallized polymer balloons." In some embodiments, the structural metal layer 90 is a metal layer 90 where the primary purpose of the metal is to improve visualization by fluoroscopy, improve biocompatibility, induce biological responses in adjacent tissue. (such as stimulating the growth of an endothelial layer on the surface of the balloon 10) or other purposes such as electrical conduction, among other purposes, but load bearing. In some embodiments, the structural metal layer 90 is a metal layer 90 with a thickness greater than 1 μm.

In some embodiments, first metal layer 90 is gold, titanium, or a combination thereof. In some embodiments, the first metal layer 90 is continuous, while in other embodiments the first metal layer 90 is discontinuous. In some embodiments, the first metal layer 90 comprises the proximal region 110, the middle region, the distal region 120, the proximal and middle regions, the middle and distal regions 120, or the proximal, middle and distal regions. formed in the area. In some embodiments, prior to creating the first metal layer 90, one or more masks are removable such that only a portion of the outer surface of the removable polymer balloon is covered with the first metal layer 90. Applied to the outer surface of the polymer balloon. In some embodiments, the removable flexible metallized polymer balloon has a rated burst pressure of 1-30 atmospheres. In some embodiments, the removable flexible metallized polymer balloon wall 30 has a thickness of 5-75 μm. In some embodiments, at least a portion of the outer surface of the removable flexible metallized polymer balloon comprises a textured surface. In some embodiments, at least a portion of the outer surface of the removable flexible metallized polymer balloon comprises a textured surface, the distance between the highest portion of the outer surface of the balloon and the lowest portion of the outer surface of the balloon is between 0.0001 and 1 μm.

In another embodiment, the first medical device 1 is made by manufacturing a first catheter 173, manufacturing a second catheter 174, manufacturing a removable polymer balloon 12 having proximal and distal openings, This creates a first polymeric layer 99 of the removable polymeric balloon 12 that is continuous except for the proximal and distal openings, expands the polymeric balloon 12, and expands the removable balloon 10 through a sputter coating or vapor deposition process. add a first metal layer 90 with a thickness in the range of 0.0005 to 1 μm on at least a portion of the outer surface of the and apply a second metal layer 90 with a thickness in the range of 1 to 50 μm through an electroforming or electroplating process. Adding to at least a portion of the outer surface of the first metal layer 90, the wall 30 of the removable metallized polymer balloon 14 is formed into a pleated, folded configuration and after expansion in the patient, the first The pleated, collapsible detachable metallized polymer balloon 14 is bonded or operably connected to the first catheter 173 in a manner that permits separation of the metallized polymer balloon 14 from the catheter 173 . In another example, the expanded detachable metallized polymer balloon 14 is expanded within the patient in a manner that allows separation of the detachable metallized polymer balloon 14 from the first catheter 173 after expansion. After being bonded or operatively connected to the catheter 173, the wall 30 of the removable metallized balloon 14 is pleated and formed into a folded configuration. Removable metallized polymer balloons 14 having structural metal layer 90 are also referred to as "rigid metallized polymer balloons" or "removable rigid metallized polymer balloons." In this context, the structural metal layer 90 is a metal layer 90 whose primary purpose is to improve visualization by fluoroscopy, improve biocompatibility, induce biological responses in adjacent tissue (balloon 10) or other purposes such as conduction of electricity, among other purposes, but load bearing. In some embodiments, the structural metal layer 90 is a metal layer 90 with a thickness greater than 1 μm.

In some embodiments, the removable rigid metallized polymer balloon is manufactured by an electroforming or electroplating process, and the second metal layer 90 comprises gold, platinum, or a combination thereof. In some embodiments, the removable rigid metallized polymer balloon is manufactured by an electroforming or electroplating process and the second metal layer 90 is continuous; The balloon is manufactured by an electroforming or electroplating process and the second metal layer 90 is discontinuous. In some embodiments, the removable rigid metallized polymer balloon is manufactured by an electroforming or electroplating process, and the second metal layer 90 comprises the proximal region 110, the intermediate region 100, the distal region 120, the proximal Formed on region 110 and intermediate region 100 , intermediate region 100 and distal region 120 , or proximal region 110 , intermediate region 100 and distal region 120 . In some embodiments, a removable rigid metallized polymer balloon is manufactured by an electroforming or electroplating process, and one or more masks are applied to the removable metallization prior to creating the second metal layer 90 . Only a portion of the outer surface of the removable metallized balloon applied to the outer surface of the balloon is covered with a second metal layer 90 . In some embodiments, removable rigid metallized polymer balloons manufactured by an electroforming or electroplating process have a rated burst pressure of 5 to 50 atmospheres. In some embodiments, the wall 30 of the removable flexible metallized polymer balloon manufactured by an electroforming or electroplating process has a thickness of 6-100 μm. In some embodiments, at least a portion of the outer surface of a removable rigid metallized polymer balloon manufactured by an electroforming or electroplating process comprises a textured surface. In some embodiments, at least a portion of the outer surface of the removable rigid metallized polymer balloon manufactured by an electroforming or electroplating process comprises a textured surface, the highest portion of the outer surface of the balloon and the lowest portion of the outer surface of the balloon. The distance between the parts is 0.0001-1 μm.

In another embodiment, the first medical device 1 is made by manufacturing a first catheter 173, manufacturing a second catheter 174, manufacturing a removable polymer balloon 12 having proximal and distal openings, This creates a first polymer layer 99 of the removable polymer balloon 12 that is continuous except for the proximal and distal openings, expands the removable polymer balloon 12 and covers at least a portion of the outer surface of the balloon 10. A first adhesive layer 95 is added and the outer adhesive coated surface of the balloon 10 expanded in a spiral, coil, braid, woven or linear pattern. 25-100 μm thick metal wire, thereby creating a first metal layer 90 and applying a second adhesive layer 95 to at least a portion of the outer adhesive coated surface and extending An adhesive layer 95 is added to at least a portion of the outer metal wire-covered surface of the detachable balloon and dried, hardened or cured to form the wall 30 of the removable metallized balloon 14, The removable metallized polymer balloon 14 is formed into a pleated, folded configuration and placed on the first catheter 173 in a manner that allows the removable metallized polymer balloon 14 to be separated from the first catheter 173 after expansion in the patient. 173. In another example, the expanded detachable metallized polymer balloon 14 is expanded within the patient in a manner that allows separation of the detachable metallized polymer balloon 14 from the first catheter 173 after expansion. The wall 30 of the removable metallized balloon 14, which is bonded or operatively connected to 173, is pleated and formed into a folded configuration. Removable metallized polymer balloons 14 having structural metal layer 90 are also referred to as "rigid metallized polymer balloons" or "removable rigid metallized polymer balloons." In this context, the structural metal layer 90 is a metal layer 90 whose primary purpose is to improve visualization by fluoroscopy, improve biocompatibility, induce the biological response of adjacent tissue (detachment). possible stimulation of the growth of the endothelial layer on the surface of the balloon 10) or other purposes such as electrical conduction, among other purposes, but load bearing. In some embodiments, the structural metal layer 90 is a metal layer 90 and the thickness of the metal wire applied to the polymer base layer 99 is greater than 1 μm.

In some embodiments, the removable rigid metallized polymer balloon is manufactured by applying a metal wire to the surface of the removable polymer balloon and the first adhesive layer comprises urethane. In some embodiments, the removable rigid metallized polymer balloon is manufactured by applying a metal wire to the surface of the removable polymer balloon and the first adhesive layer is continuous, although other implementations In form, the first adhesive layer is discontinuous. In some embodiments, the removable rigid metallized polymer balloon is manufactured by applying metal wires to the surface of the removable polymer balloon, wherein the first adhesive layer comprises the proximal region 110, the intermediate region 100, the distal formed on proximal region 120 , proximal region 10 and intermediate region 100 , intermediate region 100 and distal region 110 120 , or proximal region 110 , intermediate region 100 and distal region 120 . In some embodiments, the removable rigid metallized polymer balloon is manufactured by applying a metal wire to the surface of the removable polymer balloon and one or more masks apply the first adhesive layer. At least a portion of the outer surface of the removable polymeric balloon is coated with a first adhesive layer previously applied to the outer surface of the removable polymeric balloon. In some embodiments, the removable rigid metallized polymer balloon is manufactured by applying a metal wire to the surface of the removable polymer balloon, and the first adhesive layer is urethane in the range of 1-20%. It is formed by dipping the balloon into a solution containing urethane in a solvent with a concentration of urethane or by spraying the balloon with a solution containing urethane in a solvent with a concentration of urethane in the range of 1-20%. A removable rigid metallized polymer balloon is manufactured by applying a metal wire to the surface of the removable polymer balloon, and the metal wire is wrapped around the expanded removable balloon. When the removable rigid metallized polymer balloon is manufactured by applying a metal wire to the surface of the removable polymer balloon, the first metal layer 90 comprises gold, platinum, or a combination thereof. In some embodiments, the removable rigid metallized polymer balloon is manufactured by applying a metal wire to the surface of the removable polymer balloon, wherein the pitch and angle of the wire turns are uniform; In morphology, the pitch and angle of the wire turns are non-uniform. In some embodiments, the removable rigid metallized polymer balloon is manufactured by applying a metal wire to the surface of the removable polymer balloon and the second adhesive layer comprises urethane. In some embodiments, the removable rigid metallized polymer balloon is manufactured by applying a metal wire to the surface of the polymer balloon 12, the second adhesive layer is continuous, and in other embodiments, The second adhesive layer is discontinuous. In some embodiments, the removable rigid metallized polymer balloon is manufactured by applying a metal wire to the surface of the removable polymer balloon, the second adhesive layer being the proximal region 110, the intermediate region 100 , on distal region 120 , proximal region 110 and intermediate region 100 , intermediate region 100 and distal region 120 , or proximal region 110 , intermediate region 100 and distal region 120 . In some embodiments, the removable rigid metallized polymer balloon is manufactured by applying a metal wire to the surface of the removable polymer balloon and prior to applying the second adhesive layer, one or more A mask is applied to the outer surface of the removable metallized balloon and at least a portion of the outer surface of the removable metallized balloon is coated with a second adhesive layer. In some embodiments, the removable rigid metallized polymer balloon is manufactured by applying a metal wire to the surface of the removable polymer balloon, and the second adhesive layer is urethane in the range of 1-20%. The second adhesive layer is formed by immersing the balloon in a solution of urethane in a solvent with a urethane concentration in the range of 1-20%. Formed by spraying. In some embodiments, the removable rigid metallized polymer balloon is manufactured by applying a metal wire to the surface of the removable polymer balloon, the second adhesive layer being the proximal region 110, the intermediate region 100 , on distal region 120 , proximal region 110 and intermediate region 100 , intermediate region 100 and distal region 120 , or proximal region 110 , intermediate region 100 and distal region 120 . In some embodiments, the removable rigid metallized polymer balloon is manufactured by applying a metal wire to the surface of the removable polymer balloon and one or more masks apply a second adhesive layer. Previously applied to the outer surface of the removable metallized balloon, at least a portion of the outer surface of the removable metallized balloon is coated with a second adhesive layer. In some embodiments, a detachable rigid metallized polymer balloon manufactured by applying a metal wire to the surface of the detachable polymer balloon has a rated burst pressure of 5-50 atmospheres. In some embodiments, the wall 30 of the removable flexible metallized polymer balloon manufactured by applying a metal wire to the surface of the removable polymer balloon has a thickness of 6-400 μm. In some embodiments, at least a portion of the exterior surface of a removable rigid metallized polymer balloon manufactured by applying metal wire to the surface of the removable polymer balloon comprises a textured surface. In some embodiments, at least a portion of the outer surface of the removable rigid metallized polymer balloon manufactured by applying metal wire to the surface of the polymer balloon 12 includes a textured surface, and most of the outer surface of the balloon 10 has a textured surface. The distance between the high portion and the lowest portion of the outer surface of balloon 10 is between 0.0001 and 1 μm.

Disclosed herein are methods of making a removable polymer balloon, a removable metallized polymer balloon, a removable metallized balloon 16, and a removable polymer-coated metal balloon 18. The removable balloon may be composed of polymer only, metal only, or a combination of polymer and metal. The detachable balloon may be composed of a single polymer only, a single metal only, or a combination of a single polymer and a single metal. The removable balloon may be composed of polymers only, metals only, or a combination of polymers and metals. The removable balloon may be composed of a single polymer and multiple metals or a combination of multiple polymers and a single metal. As used herein, a removable metallized polymeric balloon includes a removable metallic polymeric balloon, a removable metalized polymeric balloon, a removable partially metallized polymeric balloon, a removable partially metallized plated polymeric balloon. Removable balloons, including removable partially metallized polymeric balloons, and removable wire-wrapped or wrapped polymeric balloons, having at least one metal region incorporated into the wall 30 of the removable polymeric balloon 12. Refers to a polymer balloon or removable balloon 10 with a continuous layer of polymer 99 except for the proximal or distal openings, if any.

In some embodiments, the metal portion of the removable metallized polymer balloon 14 or polymer-coated metal balloon 18 may be the outermost surface of the removable balloon 10 and may be the outermost surface of the removable balloon 10 . It does not have to be the surface of In various embodiments, detachable balloon 10 also includes detachable polymer-coated polymer balloon 12, detachable metallized polymer balloon 14, detachable metal balloon 16, and detachable polymer-coated metal balloon 18. , a thin polymer coating on the polymer 99 or metal 90 layer.

One method includes a metal or metal with a distal region 120, a proximal region 110 generally opposite the distal region 120, and an optional intermediate region 100 transitioning from the distal region 120 to the proximal region 110. Includes manufacture of removable balloons. A central or first axis 706 extends between proximal neck 130 and distal neck 140 of removable balloon 10 . The wall 30 of the removable balloon 10 extends continuously from the proximal region 110 through the intermediate region 100 to the distal region 120 and defines the outer surface of the removable balloon 10 and the inner surface of the removable balloon 10 . The inner surface defines a central void 115 or interior volume of the removable balloon 10 . The method includes making a removable polymer balloon and applying a metal layer 90 to the removable polymer balloon by sputtering, electroplating, electroforming, using adhesives, mechanical means, or any of these. including combinations of In one embodiment, the metal portion of wall 30 of removable balloon 10 may be continuous throughout the balloon. In another embodiment, the metal portion of wall 30 of removable balloon 10 may be discontinuous, and may include only one or more portions of wall 30 of removable balloon 10 . In one embodiment, all or part of the outer surface of removable balloon 10 may comprise metal. In another embodiment, all or part of the inner surface of removable balloon 10 may comprise metal. In another embodiment, all or part of the exterior and interior surfaces of removable balloon 10 may comprise metal. In one embodiment, none of the outer surfaces of removable balloon 10 may comprise metal. In another embodiment, none of the inner surfaces of removable balloon 10 may comprise metal. In another embodiment, neither the outer surface nor the inner surface of removable balloon 10 may comprise metal.

In some embodiments, removable metallized polymer balloon 14 may be manufactured from one or more base polymer materials. In various embodiments, the substrate is PET, nylon, Pebax, or other melt-processable aliphatic or semi-aromatic polyamides, polyurethanes (including perethane or carbotane), polyvinyl chloride, polyethylene, silicone elastomers, PTFE, and combinations thereof. Those skilled in the art will appreciate that the polymer or polymer layer of the removable metallized balloon can be made from any synthetic or natural polymer known in the art. The removable metallized balloon may use a single metal, a single metal alloy or amalgam, two different metals, two different metal alloys or amalgams, or two or more different metals, or metal alloys or amalgams. may be made by Metals that can be used include, but are not limited to, gold, platinum, iridium, silver, nickel, stainless steel, titanium, and combinations or alloys thereof.

In one embodiment, the removable metallized balloon may comprise a continuous base layer of PET (except for openings in the proximal and distal regions 110 and 120, if any) and a continuous outer layer of gold, the gold layer is <1 μm thick. In one embodiment, the removable metallized balloon may comprise a continuous base layer of PET (except for openings in the proximal and distal regions 110 and 120, if any) and a continuous outer layer of gold. The layers are >1 μm thick. In one embodiment, the removable metallized balloon may include a continuous base layer of nylon (except for openings in proximal and distal regions 110 and 120, if any) and a continuous outer layer of gold, wherein the gold layer is <1 μm thick. In one embodiment, the removable metallized balloon may comprise a continuous base layer of nylon (except for openings in proximal and distal regions 110 and 120, if any) and a continuous outer layer of gold. The layers are >1 μm thick. In one embodiment, the removable metallized balloon may comprise a continuous base layer of Pebax (except for the openings in the proximal and distal regions 110 and 120, if any) and a continuous outer layer of gold, wherein the gold layer is <1 μm thick. In one embodiment, the removable metallized balloon comprises a continuous base layer of Pebax (except for openings in the proximal and distal regions 110 and 120, if any) and a continuous outer layer of gold, the gold layer being thick. thickness >1 μm.

In one embodiment, the removable metallized balloon may comprise a continuous base layer of PET (except for openings in the proximal and distal regions 110 and 120, if any) and an outer layer of gold, wherein the gold layer is <1 μm thick and covers only part of the PET base layer. In one embodiment, the removable metallized balloon may comprise a continuous base layer of PET (excluding openings in the proximal and distal regions 110 and 120, if any) and an outer layer of gold, the gold layer being It is >1 μm thick and covers only part of the PET base layer. In one embodiment, the removable metallized balloon may include a continuous base layer of nylon (excluding openings in the proximal and distal regions 110 and 120, if any) and an outer layer of gold, the gold layer being It is <1 μm thick and covers only part of the nylon base layer. In one embodiment, the removable metallized balloon may include a continuous base layer of nylon (excluding openings in the proximal and distal regions 110 and 120, if any) and an outer layer of gold, the gold layer being It is >1 μm thick and covers only part of the nylon base layer. In one embodiment, the removable metallized balloon may include a continuous base layer of Pebax (except for the openings in the proximal and distal regions 110 and 120, if any) and an outer layer of gold, where the gold layer is It is <1 μm thick and covers only part of the Pebax base layer. In one embodiment, the removable metallized balloon may comprise a continuous base layer of Pebax (except for openings in the proximal and distal regions 110 and 120, if any) and an outer layer of gold, wherein the gold layer is >1 μm thick and covers only part of the Pebax base layer.

In one embodiment, the removable metallized balloon may comprise a continuous base layer of PET (except for openings in the proximal and distal regions 110 and 120, if any) and an intermediate layer of gold, the gold layer being thick. thickness >1 μm and covers only part of the PET base layer and an outer layer of polymer, polyurethane or silicone. In one embodiment, the removable metallized balloon may include a continuous base layer of nylon (except for openings in proximal and distal regions 110 and 120, if any) and an intermediate layer of gold, where the gold layer is It is >1 μm thick and covers only part of the nylon base layer and an outer layer of polymer, polyurethane or silicone. In one embodiment, the removable metallized balloon may include a continuous base layer of Pebax (except for openings in the proximal and distal regions 110 and 120, if any) and an intermediate layer of gold, the gold layer being thick. thickness >1 μm and covers only a portion of the Pebax base layer and an outer layer of polymer, polyurethane or silicone.

In one embodiment, the removable metallized balloon may comprise a continuous base layer of PET (except for openings in the proximal and distal regions 110 and 120, if any) and an intermediate layer of gold, the gold layer being thick. thickness >1 μm and covers all PET base layers and outer layers of polymer, polyurethane or silicone. In one embodiment, the removable metallized balloon may include a continuous base layer of nylon (except for openings in proximal and distal regions 110 and 120, if any) and an intermediate layer of gold, where the gold layer is It is >1 μm thick and covers all nylon base layers and outer layers of polymer, polyurethane or silicone. In one embodiment, the removable metallized balloon may comprise a continuous base layer of Pebax (except for the openings in the proximal and distal regions 110 and 120, if any) and the gold layer >1 μm thick. , covering all Pebax base layers and outer layers of polymer, polyurethane or silicone.

In one embodiment, the removable metallized balloon may comprise a continuous base layer of PET (except for openings in the proximal and distal regions 110 and 120, if any) and a continuous outer layer of titanium, the titanium layer being thick. <1 μm. In one embodiment, the removable metallized balloon may comprise a continuous base layer of nylon (except for openings in proximal and distal regions 110 and 120, if any) and a continuous outer layer of titanium, the titanium layer being thick. <1 μm. In one embodiment, the removable metallized balloon may comprise a continuous base layer of Pebax (except for openings in the proximal and distal regions 110 and 120, if any) and a continuous outer layer of titanium, the titanium layer being thick. <1 μm.

In one embodiment, the removable metallized balloon may comprise a continuous base layer of PET (excluding openings in the proximal and distal regions 110 and 120, if any) and an outer layer of titanium, the titanium layer being thick. <1 μm and covers only part of the PET base layer. In one embodiment, the removable metallized balloon may comprise a continuous base layer of nylon (except for openings in proximal and distal regions 110 and 120, if any) and a continuous outer layer of titanium, the titanium layer being thick. <1 μm and covers only part of the nylon base layer. In one embodiment, the removable metallized balloon may comprise a continuous base layer of Pebax (except for openings in the proximal and distal regions 110 and 120, if any) and an outer layer of titanium, the titanium layer having a thickness of <1 μm and covers only part of the Pebax base layer.

In various embodiments, the removable metallized balloon may include a continuous inner layer of PET, nylon, or Pebax, a continuous middle layer comprising gold, platinum, iridium, or silver, and a continuous outer layer of polyurethane or silicone. In various embodiments, the removable metallized balloon may comprise a continuous inner layer of PET, nylon, or Pebax, a discontinuous middle layer comprising gold, platinum, iridium, or silver, and a continuous outer layer of polyurethane or silicone. . In various embodiments, the removable metallized balloon may comprise a continuous inner layer of PET, nylon, or Pebax, a continuous middle layer comprising gold, platinum, iridium, or silver, and a discontinuous outer layer of polyurethane or silicone. .

The polymeric material of removable polymer balloon 12 or metalized polymer removable balloon 14 may be manufactured by extruding one or more polymeric materials to form removable balloon 10 . Extrusion may be accomplished by forcing one or more polymeric materials through a die to form a tube. In some embodiments, the polymeric material may be warmed or heated to soften the polymeric material prior to extrusion. In some embodiments, the polymeric material can have a melting point of about 238°C. In other embodiments, the polymeric material may have a melting point of 178°C. Those skilled in the art will appreciate that the polymeric material may have a melting point higher than the temperature used to deposit or adhere the metal onto the removable balloon 10 .

Manufacture of the polymeric material of the removable polymeric balloon or metallized polymeric balloon 14 may include preparing a mold. The mold is such that the polymeric material (e.g., balloon inner layer or base layer material) of the removable polymer balloon or metallized polymer balloon 14 manufactured from the mold is selected for the desired use (e.g., balloon inner layer or base layer structure). ) can be sized to have the desired shape and size for Uses include treating, occluding, or sealing saccular aneurysms, arteries, veins, LAAs, 800, paravalvular leak paths, other blood-containing structures, or other biological conduits 900 or spaces. may include, but are not limited to, In one example, a removable balloon intended for use in occluding a brain aneurysm may have a generally spherical shape and may have a diameter of 2-12 mm or greater than 12 mm. In another example, a removable balloon intended for use in arterial and venous occlusion may have a generally cylindrical shape and may have a diameter of 2-24 mm or greater than 24 mm. . In another example, a removable balloon intended for use in occluding the LAA may have a generally spherical or cylindrical shape and may have a diameter of 16-36 mm or greater than 36 mm. .

The mold may be used to manufacture detachable polymer balloons with proximal openings only, or proximal and distal openings. The mold may be used to manufacture removable polymer balloons with only the proximal opening and proximal neck 130 or with the proximal opening, proximal neck 130 , distal opening and distal neck 140 . Fluid from outside the removable polymer balloon can pass through the proximal opening of the removable balloon 10 and enter the central void 115 or space defined by the inner surface of the removable balloon. Detachable balloon 10 can expand when fluid enters central void 115 or space of detachable balloon 10 under pressure and detachable balloon 10 is not constrained by external forces.

The detachable balloon 10 can be expanded by deploying the balloon wall 30, by stretching the balloon wall 30 material, or by deploying the balloon wall 30 and stretching the balloon wall 30 material. Removable rigid balloons, such as removable metal balloon 16 or removable polymer-coated metal balloon 18, expand primarily upon deployment. A detachable compliant balloon, such as a detachable silicone balloon, expands primarily by stretching only the material of the balloon wall 30 . A detachable semi-elastic balloon, such as a PET, nylon or Pebax detachable balloon, expands upon deployment and by stretching the material of the balloon wall 30 where deployment prevails. In various embodiments, one or both necks can project away from the wall 30 of the removable balloon 10, or they can project into the central void 115 or space of the removable balloon 30. can.

Removable balloon necks 130 and 140 and neck assemblies 135 and 142 are used to attach removable balloon 10 to first catheter 173 and to attach removable balloon 10 to second catheter 174. can be done. Detachable balloon necks 130 and 140 and neck assemblies 135 and 142 may be responsible for separating the expanded detachable balloon 10 from the first catheter 173 . In one example, an elastomeric tubular structure 204 can be coupled to the proximal neck 130 of the removable balloon 10 and used to form a friction fit 202 with the distal end of the first catheter 173. can. After expansion of the removable balloon 10, the third catheter 175 can be advanced forward until it abuts the proximal end of the elastomeric tubular structure 204, retracting the first catheter 173 and removing the removable balloon. The dilatation balloon 10 and first catheter 173 can be separated. In another example, an elastomeric or elastic valve 192 is used to couple the distal neck 140 or distal neck assembly 142 of the removable balloon 10 to form a friction fit 202 with the distal portion of the second catheter 174 . can do. After expansion of the detachable balloon 10, the third catheter 175 is advanced forward until it abuts the proximal neck 130 of the detachable balloon 10 or the proximal region 110 of the detachable balloon 10, and the second catheter 175 is advanced. 174 is pulled back resulting in separation of the expanded removable balloon 10 and second catheter 174 . In another example, female tubular structure 520 is attached to proximal neck 130 of removable balloon 10 and male tubular structure 510 is attached to the distal end of first catheter 173 and removable balloon 10 . The combined first catheter 173 and removable balloon 10 are combined by mating male and female tubular structures 510 and 520 and inserting the second catheter 174 through the lumen of the mated portions. can do. After the detachable balloon 10 has been expanded in vivo, the second catheter 174 can be withdrawn and the first catheter 173 separated from the expanded detachable balloon 10 .

The removable balloon neck and neck assembly can be designed and sized to provide a point for attaching the retention structure 731 to the removable balloon. In one embodiment, a self-expanding nitinol retention structure 731 comprising a proximal ring and distal arms and hooks 733 can be coupled to the distal neck 140 of the removable balloon. In another embodiment, a self-expanding nitinol retention structure 731 comprising proximal and distal rings with elongated structures comprising barbs 608 or hooks 733 inserted between the proximal and distal rings is removable. It can be glued to the proximal neck 130 of the balloon 10 .

The removable balloon neck and neck assembly can be designed and dimensioned to reduce fluid leakage from the central void 115 of the removable balloon 10 portion of the removable balloon catheter 1 during balloon expansion. In some embodiments, a tubular structure 185 having an inner diameter or lumen diameter that closely matches the outer diameter of the second catheter 174 can be coupled to the distal neck 140 of the removable balloon. If the second catheter 174 extends through this tubular structure 185, the length of the tubular structure and the width of the gap between the tubular structure 185 and the second catheter 174 will be sufficient for injection into the central void 115 of the balloon. This may affect the leakage rate of the fluid being applied and reduce the time required for the removable balloon 10 to fully inflate. In some embodiments, a tubular structure 190 having an inner diameter or lumen diameter that closely matches the outer diameter of the first catheter 173 can be coupled to the proximal neck 130 of the removable balloon 10 . When the distal end of the first catheter 173 is inserted into this proximal neck tubular structure 190, the length of the tubular structure 190 and the width of the gap between the tubular structure 190 and the first catheter 173 are the balloon The leakage rate of fluid injected into the central void 115 of 10 may be affected, reducing the time required for the removable balloon 10 to fully inflate.

The removable balloon neck and neck assembly can be designed and dimensioned to enhance the fluoroscopicity of the balloon neck and neck assembly. In some embodiments, a ring-shaped or tubular structure comprising a radiopaque metal visible under fluoroscopy is coupled to the inner or outer surface of the proximal or distal necks 130 and 140 to be removable in vivo. visualization of the detachable balloon portion of the balloon catheter 1 can be improved. In some embodiments, the proximal or distal necks 130 and 140 of the detachable balloon 10 are coated with a layer of radiopaque metal visible under fluoroscopy during electroforming or electroplating of the polymer detachable balloon. to improve visualization of the removable balloon portion of the removable balloon catheter 1 in vivo.

The removable balloon neck and neck assembly can be designed and sized to reduce the risk of air embolism in vivo. In most interventional procedures using balloon catheters, a small amount of air remains inside the balloon during use. With standard angioplasty balloon catheters, except for inadvertent balloon rupture, this air remains trapped within the balloon during use and is removed when the angioplasty balloon catheter is removed. When using a detachable balloon catheter 1, residual air trapped within the balloon remains in the patient with the balloon, with the attendant risk of embolization of that air into the distal circulation, causing particularly severe effects on the cerebral circulation. there is a possibility. As shown in FIG. 12, the coupling of the tubular structure to the proximal and distal necks 130 and 140 of the removable balloon is such that the tubular structure extends into the central void 115 of the removable balloon and is separated. Leakage of air trapped in the balloon can be reduced.

In some embodiments, one or more necks or neck assemblies can be closed or partially closed before, during, or after separation of the expanded removable balloon from the first catheter 173. It can be designed and sized to include an aperture. For example, an elastomeric or elastic valve 192 is optionally placed within a distal nosecone 191 with one or more spacers 196 proximal, distal, or both proximal and distal to the valve. can be included in A valve-containing distal nosecone 191 can be coupled to the removable balloon distal neck 140 or distal neck assembly 142 . During assembly of the detachable balloon catheter 1, a second catheter 174 is inserted through the valve 192 to create an over-the-wire device and detachable with the catheter assembly 5 of the detachable balloon catheter 1. The attachment strength between the balloon catheter 1 and the detachable balloon 10 can be increased. After expansion of the removable balloon within artery 317 or vein 318 and separation of the expanded balloon from catheter assembly 5 , elastomeric or elastic valve 192 closes, thereby passing through central void 115 of inflated balloon 10 . stop or reduce the flow of blood;

The removable balloon neck may have a length in the range of about 0.5mm to 60mm, preferably about 0.5mm to about 5mm. The neck may define an opening having a diameter between about 0.25mm and about 5mm. The neck has a diameter in the range of about 0.25 mm to about 5 mm and preferably has a length in the range of about 1 mm to 60 mm, preferably about 0.25 mm to about 5 mm, while defining an opening having a diameter of about 0.25 mm to about 5 mm. It may protrude into the central void 115 or space over a length of 5 mm to 5 mm. The wall thickness of one or both necks may be the same as the removable balloon body 100, thinner than the walls 30 of the removable balloon body 100, or thicker than the walls 30 of the removable balloon body 100. may Preferably, either or both necks have a wall 30 thickness of between about 3 μm and about 300 μm, with a typical thickness of 60 μm or less. In detachable balloon embodiments where the proximal and distal necks 130 and 140 extend into the central void 115 or space of the detachable balloon 10, the outer surface of the detachable balloon 10 retains a more rounded surface contour, As such, placement of the removable balloon 10 may reduce the risk of damage to the vessel wall or adjacent tissue.

A variety of expanded and detachable balloon shapes are available for treating saccular aneurysms, vessel segments, LAAs, other blood-containing structures, biological conduits 900, or biological spaces of various shapes. Permissible. In various embodiments, the mold can be used to manufacture the removable polymer balloon or portion of the removable polymer balloon, wherein the dimensions of the removable polymer balloon or portion of the removable polymer balloon are sac-like. The selection is based on the size and shape of the aneurysm, artery or vein segment, LAA, other blood-containing structure, or biological conduit 900 segment or space being treated.

The preferred shape of the removable balloon for treatment of arteries, veins, and other biological conduits 900 is cylindrical with conical ends because it does not need to provide rounded surfaces for the flow of blood or other biological fluids. Conical end shapes typically provide the lowest profile and outer diameter after pleating and folding. The length of the middle region of the detachable balloon can affect occlusion performance. A longer intermediate region is generally preferred, if possible, because there is less blood leakage around an inflated balloon that has a longer contact surface with adjacent tissue. For arterial and venous occlusion, longer intermediate regions are preferred, especially with removable polymer balloons and flexible removable metallized polymer balloons. As such, removable balloons for occluding arteries, veins, and other biological conduits 900 are often longer than they are wide. With removable rigid metallized polymer balloon 14, removable metal balloon 14, and removable polymer-coated metal balloon 18, increasing the length of middle region 100 of the removable balloon results in a removable balloon catheter. The distal portion of 1 is stiffer and less deliverable.

The dimensions of a typical saccular aneurysm 320, including distal bifurcation aneurysms and sidewall aneurysms, are defined in FIGS. 92A-92C, 95A and 96A. The preferred shape of the removable balloon for treatment of saccular aneurysm 320 is spherical or cylindrical with a short intermediate region. The length or diameter of the removable balloon 10 along the second axis 708 is important as it determines the diameter of the aneurysm neck 324 that can be covered and occluded. The length or diameter of balloon 10 along first axis 706 is also important, as longer lengths and diameters along this axis will bring the tip of second catheter 174 closer to the dome of aneurysm 320, which is is typically the most vulnerable part of the aneurysm 320 and most susceptible to rupture or puncture. Therefore, when selecting balloon 10 to treat saccular aneurysm 320, the length or diameter of second shaft 708 should be sufficient to cover aneurysm neck 324 but not longer than the aneurysm width. 10 is important, as is the balloon 10 that still has the smallest effective length or diameter along the first axis 706 . When using this configuration of balloon 10 to treat saccular aneurysm 320, the unfilled body and dome of aneurysm 320 can be filled with one or more coils or elongated bodies 720, which are: Generally softer and less traumatic to the aneurysm wall than the distal neck 140 of the removable balloon catheter 1 or the second catheter 174 . As such, removable balloons 10 for treatment of saccular aneurysms 320 are often wider than they are long. A rounded proximal region 110 is preferred because the proximal region 110 of the removable balloon 10 positioned within the saccular aneurysm 320 faces the blood. Given that the dome of the aneurysm 320 is often fragile, a rounded distal region 120 is also preferred over a conical or square distal end.

A preferred shape of the removable balloon 10 for treatment of LAA 800 includes a cylindrical shape with an intermediate length and an intermediate region that is rounded ends. The LAA 800 is generally long, and the LAA 800 "dome" is not particularly fragile and less susceptible to rupture or puncture, thus allowing a removable balloon 10 having a longer intermediate region. A rounded proximal region 110 is preferred because the proximal end 110 of the removable balloon 10 placed in the LAA 800 faces the blood. Preferred shapes for the removable balloon 10 for treatment of paravalvular leaks include a cylindrical shape with a long middle region and rounded or conical ends. Rounded proximal and distal regions 110 and 120 are preferred because both the proximal and distal ends of a removable balloon placed in a paravalvular leak face blood.

For example, the removable balloon 10 or a portion of the removable balloon 10 may be configured as a cylinder with rounded, hemispherical, conical, or flat ends. The diameter of the cylindrical expanded detachable balloon 10 or a portion of the detachable balloon 10 can range from about 2 mm to about 30 mm. The expanded length of the rectangular removable balloon can range from about 5 mm to about 60 mm. The removable balloon may have an expanded volume ranging from about 0.005 mL to about 65 mL. The expanded diameter of the cylindrical removable balloon ranges from about 2 mm to about 40 mm, the expanded volume ranges from about 0.004 mL to about 40 mL, and the expanded diameter of the spherical removable balloon ranges from about 0.004 mL to about 40 mL. The length may range from about 2 mm to about 20 mm.

The removable balloon has one or more openings defined by wall 30 or one or more necks 130 and 140 . In various embodiments, one or both of necks 130 and 140 can project away from the wall of removable balloon 10 or into the central void 115 or space of the removable balloon. Additionally, the neck 130 or 140 can be designed and dimensioned to close or partially close the opening before, during, or after separation of the expanded breakaway balloon 10 from the first catheter 173 . The neck has a length in the range of about 0.5mm to 60mm, preferably about 0.5mm to about 5mm. Necks 130 and 140 may define openings having diameters between about 0.25 mm and about 5 mm. Necks 130 and 140 preferably have lengths ranging from about 1 mm to 60 mm, while defining openings having diameters between about 0.25 mm and about 5 mm, preferably between about 0.25 mm and about 5 mm. may protrude into the central void 115 or space with a length of about 0.5 mm to 5 mm. The wall 30 thickness of either or both necks 130 and 140 may be the same, thinner, or thicker than the wall 30 of the body 100 of the removable balloon 10 . One or both of necks 130 and 140 have a wall thickness 30 of between about 3 μm and about 500 μm. In one embodiment of removable balloon 10 in which necks 130 and 140 extend into central void 115 or space of removable balloon 10, the outer surface of removable balloon 10 retains a more rounded surface profile, thus providing a more rounded surface profile for removal. Possible balloon 10 placements may reduce the risk of injury to the vessel wall or adjacent tissue.

In other embodiments, one or more portions of detachable balloon wall 30 may be thicker than the remainder of wall 30 . By way of example and not limitation, walls 30 of body or intermediate region 100 of detachable balloon 10 are thicker than walls of proximal region 110 and distal region 120 or necks 130 and 140 of detachable balloon 10 . By way of example and not limitation, the wall 30 of the removable balloon proximal region 120 may be thicker. By way of example and not limitation, walls 30 of proximal region 120 of removable balloon 10 may be thicker than walls of distal region 140 of removable balloon 10 or walls of necks 130 and 140 . By way of example and not limitation, walls 30 of distal region 120 of detachable balloon 10 may be thicker than walls 30 of proximal region 110 of detachable balloon 10 or walls 30 of necks 130 and 140 . By way of example and not limitation, walls 30 of intermediate region 100 and walls of proximal and distal necks 130 and 140 of detachable balloon 10 are thicker than walls of proximal and distal regions 110 and 120 of detachable balloon 10 . good too. By way of example and not limitation, walls 30 of proximal neck 130 and distal neck 140 may be thicker than walls 30 of intermediate region 100 of removable balloon 10 .

The removable metallized polymer balloon 14 may be manufactured using a variety of extrusion and molding techniques using an "inner layer" material or a "base layer" material, the inner layer or base layer material being removable. The material used to make the removable balloon inner layer or base layer structure that is formed into a portion of the balloon or removable balloon is a polymer. Those skilled in the art will appreciate that any process known in the art for manufacturing balloons can be used to manufacture the removable balloon innerlayer or baselayer structure.

The removable balloon inner layer or base layer structure may be manufactured by using various types of molding processes. In some embodiments, the removable balloon is subjected to blow molding, compression molding, extrusion molding, injection molding, matrix molding, rotational molding. rotational molding, thermoforming, transfer molding, vacuum assisted resin transfer molding, vacuum forming, or any molding known in the art You may manufacture using a means. The removable balloon inner layer or base layer structure may be made using a variety of extrusion techniques. Those skilled in the art will appreciate that any manufacturing method known in the art can be used.

The material used to form the inner layer or base layer structure of the removable balloon may begin in the form of a billet that may be placed in a container and forced through a die opening. Making a mold for the removable balloon inner layer or base layer structure may be accomplished using direct or forward extrusion techniques known in the art in which the billet is forced through a stationary container. Manufacture of the removable balloon inner layer or base layer structure may be accomplished by using indirect or backward extrusion in which the billet and container move together and push the billet through a die. Making a mold for the removable balloon inner layer or base layer structure may be accomplished by hydrostatic extrusion in which the billet is surrounded by a pressurized liquid. The extrusion method used includes the use of one or more dies configured to provide an extruded material with both an inner surface and an outer surface. Those skilled in the art will appreciate that the mold for the removable balloon inner layer or base layer structure may be manufactured by any extrusion means known in the art.

Detachable polymeric balloons or detachable balloons including removable balloon inner or base layer structures may be manufactured from a variety of materials, including polymers, using blow molding techniques. The blow molding technique may involve heating the removable balloon inner layer or base layer material to a temperature that softens or softens the removable balloon inner layer or base layer material. This temperature may be the melting point of the removable balloon inner layer or base layer material. Suitable temperatures for softening or melting the removable balloon inner layer or base layer material may vary based on the removable balloon inner layer or base layer material. If PET is the removable balloon inner layer or base layer material, the removable balloon inner layer or base layer material may be heated to about 238°C. The removable balloon inner layer or base layer material may be a material without a defined melting point. If the removable balloon inner layer or base layer material does not have a melting point, the base material may be heated to its Vicat softening temperature.

Blow molded removable balloon inner layer or base layer structures may be made from cut sections of extruded removable balloon inner layer or base layer material. The cut may be about 18 inches long. The cut may be 10 inches long. The cut may be 24 inches long. A person skilled in the art will understand that the cut can be any length known in the art. The cut may have any diameter known in the art. In some embodiments, a blow molded removable balloon inner layer or base layer structure may be manufactured using a preform.

A cut portion of the extruded removable balloon inner layer or base layer material may be heated to a suitable temperature to soften the material. The heated removable balloon inner layer or base layer material may be extruded into a hollow tube or parison. The softened parison may be placed in a mold for a removable balloon inner layer or base layer construction that is closed around the softened parison. Once in the removable balloon inner layer or base layer structure mold, fluid or air is forced or blown into the parison, allowing the parison to assume the shape of the removable balloon inner layer or base layer structure mold. The air forced into the parison must provide sufficient pressure to the inner diameter of the parison to expand the parison onto the mold surface. Those skilled in the art will understand that fluid or air can be blown into either end of the parison. The removable balloon mold may have a temperature below the temperature of the softened parison. The mold of the removable balloon inner layer or base layer structure keeps the softened parison soft until the softened parison is filled with sufficient air to conform to the mold of the removable balloon inner layer or base layer structure. may have a temperature sufficient for In some embodiments, the removable balloon inner layer or base layer structure mold has a warm flexibility before the softened parison is placed in the removable balloon inner layer or base layer structure mold. It may have a temperature lower than that of the parison. The heated base material must be properly oriented. Proper placement of the parison requires that the softened portion be contained in a cavity so that the parison can be remolded against the internal structure of the removable balloon inner layer or base layer structure mold.

The removable balloon may be made using injection blow molding in which the inner or base layer material of the softened removable balloon is injection molded onto the core pin. The core pin may be configured to provide pressure to the inner surface of the removable inner balloon layer or base layer material. After the removable balloon inner layer or base layer material is deposited on the core pin, the core pin may be placed in a removable balloon inner layer or base layer structure mold that is closed around the core pin and base material. The fluid is forced or blown into the inner surface of the removable balloon inner layer or base layer material to expand the removable balloon inner layer or base layer material and to form a removable balloon inner layer or base layer structure. It may be adapted to the internal shape. The mold for the removable balloon inner layer or base layer construction may have an initial temperature that keeps the removable balloon inner layer or base layer material soft. The mold for the removable balloon inner layer or base layer structure may have a temperature low enough to fix the molded shape. Those skilled in the art will appreciate that the mold temperature of the removable balloon inner layer or base layer structure is lowered to fix the removable balloon inner layer or base layer material to the desired shape of the removable balloon inner layer or base layer structure. It will be appreciated that the removable balloon inner layer or base layer structure can be reshaped to keep the removable balloon inner layer or base layer material soft until it is molded into the desired shape. In some embodiments, a suitable device, such as a core rod, may be used to reheat the removable balloon inner layer or base layer structure to stretch the removable balloon inner layer or base layer structure.

The formed removable balloon inner layer or base layer structure is further processed using processes such as trimming away excess material by rotating a knife or blade around the removable balloon inner layer or base layer structure. and may be molded. At this point, the removable balloon inner layer or base layer structure can be applied to the removable balloon of the removable balloon catheter 1 without applying additional layers or surface coatings to the removable balloon inner layer or base layer structure. may be manufactured to In these embodiments, the removable balloon inner layer or base layer structure is a polymer balloon and can be used to make a removable balloon catheter 1 with a removable polymer balloon 10 . Alternatively, additional layers or coatings can be applied to the structure of the inner layer or base layer 99 of the polymer balloon 12 to create a polymer-coated polymer balloon or metallized polymer balloon 14 .

Fabricating the inner layer or removable balloon base layer 99 structure may include bonding needles to the removable balloon inner layer or base layer structure. Bonding the needle to the inner layer or base layer structure of the removable balloon is critical for part fabrication. A bonded needle may be useful to facilitate simplified handling and testing of removable balloon innerlayer or baselayer structural assemblies. In this regard, the proximal end of the removable balloon inner layer or base layer structure may be flared and coupled to the needle. The needle may be attached to the distal end of the removable inner balloon layer or base layer structure. In some embodiments, needles may be coupled to both the proximal and distal ends of the removable inner balloon layer or base layer structure. Binding may be accomplished by any means known in the art. One bonding method may include providing a UV curable adhesive and applying the adhesive to the ends of the removable balloon inner layer or base layer structure. In embodiments where only one end of the removable balloon inner layer or base layer structure is attached to the needle, the opposite end may be occluded. Occlusion may be accomplished using a UV curable adhesive. The occlusion is heated until the ends of the removable balloon inner layer or base layer structure become pliable, at which point the ends of the removable balloon inner layer or base layer structure change shape until they are closed. may be achieved by Those skilled in the art will appreciate that occlusion and coupling can be accomplished by any means known in the art. Also, those skilled in the art should be able to replace the needle with any tool known in the art to aid in simplified handling and testing of removable balloon inner or base layer structures, or polymeric balloons. will also understand.

The removable balloon inner layer or base layer structure may be coated using a variety of techniques. In some embodiments, the removable balloon innerlayer or baselayer structure may be coated using one or more of these processes: sputter coating or deposition, vapor deposition, electroforming or electroplating. . The method of forming the outer layer may further comprise forming pores or protrusions.

Coating of the removable balloon inner layer or base layer structure may be accomplished by physical vapor deposition. In some embodiments, physical vapor deposition is accomplished using sputter deposition, where material is released from a source material and deposited onto a removable balloon. Sputter deposition is a process performed in a vacuum chamber environment. Special process considerations are required to handle inner or base layer structures of removable balloons in a vacuum environment. It is important to maintain the shape of the removable balloon inner layer or base layer structure in the vacuum so that the removable balloon inner layer or base layer structure is sufficiently coated. To maintain the shape of the removable balloon inner layer or base layer structure in a vacuum environment, the pressure within the removable balloon inner layer or base layer structure must be greater than or equal to the pressure outside the removable balloon inner layer or base layer structure. must. In some embodiments, the removable balloon inner layer or base layer structure is vented to a vacuum chamber, thus providing equal pressure inside and outside the removable balloon inner layer or base layer structure. In other embodiments, the removable balloon inner layer or base layer structure exceeds a pressure that causes the removable balloon inner layer or base layer structure to deform or rupture. It is attached to a manifold that allows a positive pressure to be maintained relative to the vacuum chamber pressure without pressure. To maintain pressure equilibrium or positive pressure between the inside and outside of the removable balloon, the removable balloon may be fluidly connected to a device that assists in maintaining pressure equilibrium. The device for maintaining pressure equilibrium may be a sputter rack. The sputtering rack may be flat so that it can be sputtered one side at a time. The sputtering rack may be configured to allow simultaneous double-sided sputtering. The sputter rack may include manifolds. A manifold may be fluidly connected in parallel to one or more removable balloons. The removable balloons may be fluidly connected to the manifold in series. The removable balloon inner layer or base layer structure may be fluidly connected to the manifold via needles connected to the removable balloon. In some embodiments, a Luer connection may be used to connect the needle to the manifold. Those skilled in the art will appreciate that any means known in the art for fluidly connecting needles can be used to connect the needles to the manifold. A balancing balloon may be fluidly connected to the manifold to maintain equilibrium between the inner and outer portions of the removable balloon inner layer or base layer structure. The balance balloon may expand as the pressure within the chamber decreases. The balance balloon may provide pressure to the inner surface or central void 115 of one or more removable balloon inner layers or base layer structures fluidly connected to the manifold. In some embodiments, the sputter rack is fluidly connected to 1, 2 to 6, 7 to 12, 12 to 40, or more than 40 removable balloon inner layer or base layer structures. be done. Those skilled in the art will appreciate that the sputter rack can be fluidly connected to any number of removable balloon innerlayer or baselayer structures.

Sputter deposition may be accomplished using several steps. Components such as removable balloon liner or base layer structures, needles, and manifolds may be marked to identify various aspects of the removable balloon liner or base layer structures. The markings may be used to identify the composition of the inner layer or base layer structure of the removable balloon. The markings can identify the configuration of the inner layer or base layer structure of the removable balloon. After marking the various components, the sputtering rack may be loaded into the removable balloon inner layer or base layer structure. The removable balloon inner layer or base layer structure may be fluidly connected to the rack via a needle Luer connection. Those skilled in the art will appreciate that the connection between the rack and the needle can be any connection known in the art. Once the removable balloon inner layer or base layer structure is deployed, the pressure within the manifold can increase. Increasing the manifold pressure may result in increased pressure within the removable balloon inner layer or base layer structure. This increase in pressure may remove wrinkles and creases in the inner layer or base layer structure of the removable balloon. Those skilled in the art will appreciate that the pressure increase should be increased enough to remove wrinkles, but not enough pressure to damage the removable balloon inner layer or base layer structure. deaf. In some embodiments, the pressure is increased by fluidly connecting the syringe to the manifold. Pressure may be increased by pumping air into the manifold. Those skilled in the art will appreciate that the pressure can be increased using any means known in the art.

After wrinkles or creases have been removed from the removable balloon inner layer or base layer structure, the syringe or other pumping device may be removed from the spatter rack and removed. A balancing balloon may be deflated and placed on the manifold and pushed into the tunnel. The balance balloons may be fluidly connected to the rack via tubes or hoses by suitable means. The balance balloon may be placed in a tube or other containment method that allows expansion of the balance balloon under vacuum while controlling the position of the balance balloon during the vacuum phase. The balance balloon may be placed in a containment chamber to prevent the balance balloon from growing too large during the sputtering process. The balance balloon may be placed in the containment chamber by lowering it via gravity, pushing it into place by known means, or pulling it into place. A sputter rack may then be placed in a vacuum chamber and air may be evacuated from the vacuum chamber to or near vacuum pressure. A sputter deposition process may include a target that is a source of coating material. A sputter deposition process may include the substrate positioned such that material from the target is ejected toward the substrate. The substrates in the vacuum chamber are individual removable balloon innerlayer or baselayer structures. The target may be bombarded by a high-speed plasma stream of gas. The etching species can be any etching species known in the art. In some embodiments, the etching species can be charged or neutral. Those skilled in the art will appreciate that the etching species can be any gas suitable for plasma etching a source or target. The duration of the etching process may vary from no etching to the maximum amount of etching allowed without distorting the removable balloon inner layer or base layer structure.

The target or source consists of gold, platinum, silver, titanium, vanadium, aluminum, nickel, tantalum, zirconium, chromium, silicon, magnesium, niobium, scandium, cobalt, palladium, manganese, molybdenum, alloys thereof and combinations thereof It may be made from a metal selected from the group. Other biocompatible rigid materials or combinations of materials may be used. The target or source is 1 Angstrom to 10,000 Angstroms thick, preferably 50 to 500 Angstroms thick, for a time sufficient to deposit titanium on the surface of the inner layer or base layer structure of the removable balloon. may be impacted over The source is 1 Angstrom to 10,000 Angstroms thick, preferably 250-5000 Angstroms, or 1000 Angstroms thick, and is sufficient to deposit gold on the surface of the inner layer or base layer structure of the removable balloon. may be impacted for an extended period of time. In some embodiments, titanium may be deposited onto the removable balloon inner layer or base layer structure prior to gold deposition. In some embodiments, gold may be deposited on the surface of the removable balloon inner layer or base layer structure prior to titanium deposition. In some embodiments, once a sufficient coating of metal has been deposited on one side of the removable balloon inner layer or base layer structure, the removable balloon inner layer or base layer structure is placed in an anti-chamber chamber from which the vacuum can be released. (anti-chamber). The pallet is coated on the other side of the removable balloon inner layer or base layer structure using the method used to coat the first side of the removable balloon inner layer or base layer structure. may be flipped, rotated, or moved for In some embodiments, the removable balloon inner layer or base layer structure may be placed in a sputtering environment that allows both sides of the removable balloon inner layer or base layer structure to be coated without the need to reposition the sputtering rack. good. A coated removable balloon inner layer or base layer structure may be placed in custom packaging tubes. Those skilled in the art will appreciate that the coated removable balloon inner layer or base layer construction can be placed in any packaging known in the art.

The removable balloon inner layer or base layer structure may also be coated using electroplating techniques. This includes electroplating a removable balloon inner layer or base layer structure having a metallic outer surface layer, including a metallic outer surface layer fabricated by vapor deposition or sputtering. Electroplating generally involves dissolving a metal in a circulating solution such that at least a portion of the coating of the metal surface layer or removable balloon inner layer or base layer structure is covered or coated with the metal circulating in the solution. immersing the metal surface layer or coating in solution until the Those skilled in the art will appreciate that additional surface layers of metal can be added to the metal surface layer or coating of the removable balloon inner layer or base layer structure using any electrodeposition method known in the art. deaf. As with conventional electroplating, anode 390 and cathode 405 are submerged in a circulating metal solution. In the present disclosure, anode 390 may be any conventional anode known in the field of electrodeposition. The inner layer of the metal-coated removable balloon or the surface of the base layer structure serves as the cathode 405 and is coated on the outside with metal circulating in solution. The negative side of the electroplating power supply, using a support fixture or other support structure, to achieve the necessary electrical conductivity for electroplating the surface of the inner layer or base layer structure of the metal-coated removable balloon. Make an electrical contact to In some embodiments, a hypodermic tube splint may be inserted into the needle. The hypotube splint may include one or more openings that allow fluid to pass from an external source to the internal voids of the metallized removable balloon inner layer or base layer structure. The hypotube splint may include a connection for connection to a female Luer hub. The assembly may further include a unidirectional injection port. Those skilled in the art will appreciate that the hypotube splint may have any means of connecting to a needle known in the art. Metal-coated removable balloon inner layer during electroforming or electroplating or removable metal-coated removable balloon during electroforming or electroplating to promote uniform deposition of metal on the outer surface of the base layer structure The inner balloon layer or base layer structure may be rotated. The hypotube splint may be attached to a rack or similar device that includes means for rotating the metallized removable balloon inner layer or base layer structural assembly. A hypotube splint may be connected to the needle injection port and rack assembly to suspend the metallized removable balloon inner layer or base layer structure in a bath. A support structure that allows electrical connection of the needle while maintaining the position of the needle within the electroforming or electroplating solution is preferred. The support structure may use gears, belts, pulleys or other suitable means to rotate one or more of the individual metal-coated removable balloon innerlayer or baselayer structures. The support structure also provides a common electrical connection so that the metallized removable balloon innerlayer or baselayer structure is referenced at an electrical potential that facilitates electroforming or electroplating. The metallized removable balloon inner layer or base layer structure may be immersed in an electroforming or electroplating bath at a temperature of 100°F to 250°F, or about 160°F. Those skilled in the art will recognize that the bath can be at any temperature necessary to successfully electroform or electroplate the metallized removable balloon inner layer or base layer structure with the metal circulating in the solution. . Metals circulating in the solution include gold, platinum, silver, titanium, vanadium, aluminum, nickel, tantalum, zirconium, chromium, silicon, magnesium, niobium, scandium, cobalt, palladium, manganese, molybdenum, their alloys and their alloys. It may be a metal selected from the group consisting of a combination or other conductive, biocompatible, rigid, or semi-rigid materials or combinations of materials.

The central layer of wall 30 of removable balloon 10, the inner layer of wall 30 of removable balloon 10, and the outer layer of wall 30 of removable balloon 10 may be formed by any suitable method. In some preferred embodiments, wall 30 of removable balloon 10 has two layers. The inner layer of the wall 30 of the removable balloon 10 comprises PET, Nylon or Pebax and is formed by blow molding fabrication. The outer layer of wall 30 of removable balloon 10 includes a metal layer 90 comprising gold or titanium formed by sputter deposition or vapor deposition. In some preferred embodiments, the removable balloon 10 has three layers. The inner layer of wall 30 of removable balloon 10 comprises PET, nylon, or Pebax and is formed by a blow molding process. The central layer of wall 30 of removable balloon 10 comprises gold or titanium formed by sputter deposition or vapor deposition. The outer layer of wall 30 of removable balloon 10 comprises gold or platinum formed by electroforming or electroplating.

In some embodiments, a conductive mandrel 740 is placed in a solution of metal ions and coats the outer surface of the mandrel 740 to form a removable balloon layer. For example, in some preferred embodiments, the conductive mandrel 740 is a removable balloon inner layer or base layer structure comprising a polymer formed by a blow molding process. The inner layer or base layer structure of the removable balloon is coated with gold or titanium on its outer surface by sputter deposition or vapor deposition. The shape of the mandrel 740 (and thus the shape of the removable balloon) can be changed by changing the shape of the polymer inner layer or base layer formed by the blow molding process. The thickness of any layer of the removable balloon, including but not limited to metal or metal layers, can be varied by varying process times or conditions. Additional surface layers may be formed by additional electroplating or electroforming. Additional surface layers may be formed by evaporation or sputter deposition, where material is eroded from a target (eg, a metal or metal alloy) and deposited onto a substrate, such as a mandrel 740 or mold, to form a thin layer on the substrate. to form Similarly, the inner layer may be formed by additional electroplating or electroforming, or by evaporation or sputter deposition. In another exemplary method of forming a removable balloon, the central layer of wall 30 of removable balloon 10 can be formed by vapor deposition, vapor deposition from one or more polymers, pure metals, or alloys. is condensed on the substrate or mold. The mold may be removed to provide a hollow shell composed of polymer, pure metal or metal alloy. In various embodiments, after deposition or formation of one or more metal layers 90, the outer surface of the removable balloon may be further coated with a polymer, such as by using a polymer-containing solution. This additional coating may include an outer coating of a urethane-containing solution that may further act to secure the metal or metal layers to the removable balloon containing the inner or base layer.

In various embodiments, only desired portions or regions of the removable balloon include a metal layer 90 deposited by electroforming or electroplating. In various embodiments, only portions or regions of the metallized removable balloon inner layer or base layer structure are further coated with additional metal by electroforming or electroplating. In various embodiments, various portions or regions of the removable balloon may have different wall configurations or thicknesses. In some embodiments, different wall structures or thicknesses are produced by masking portions or regions of the removable balloon inner layer or base layer structure prior to vapor deposition or sputter deposition. In some of these embodiments, additional metal may be applied to portions or regions of the metal-covered removable balloon inner layer or base layer structure by vapor deposition or sputter deposition. In some embodiments, different wall structures or thicknesses are produced by masking or coating areas of the metal coated removable balloon inner layer or base layer structure prior to electroforming or electroplating. be done. In some of these embodiments, additional metal is applied to portions or regions of the masked or uncoated metal coated removable balloon inner layer or base layer structure prior to electroforming or electroplating. good too.

According to various embodiments, the metal layer 90 of the removable balloon may comprise various patterns. For example, one or more masks may be applied to the outer surface of the removable balloon inner layer or base layer structure prior to further coating with a polymer or metal. In some embodiments, a first metal or metal layer is applied by sputter deposition, then a second metal layer 90 is formed by electroforming or electroplating, and one or more masks are applied to the first metal layer. may be applied before or after the formation of the For these embodiments, various portions of the removable balloon inner layer or base layer structure may have no metal layer 90 , one metal layer, or two or more metal layers 90 . The one or more outer metal layers may be deposited as one or more narrow bands, an arcuate configuration, multiple bands of uniform different widths, multiple bands of different widths, or combinations thereof. Those skilled in the art can appreciate that other configurations can be provided.

In some embodiments, the removable balloon can comprise a metallized polymer balloon, wherein the metal layer 90 is incomplete, discontinuous, or present only on a portion of the wall 30 of the removable balloon 10. ing. Such incomplete or discontinuous layers may be produced by electroplating, electroplating, vapor deposition or sputter deposition. In some removable balloon embodiments, a metal layer 90 is formed on the polymeric inner layer or base layer structure, and some regions or portions of the walls 30 of the removable balloon 10 are electroformed or electroplated. and other areas or portions of the removable balloon without metal layer 90 manufactured by electroforming or electroplating. In some embodiments, the removable partially metallized polymer balloon 20 has a central or intermediate region 100 comprising a layer of gold manufactured by electroforming or electroplating that is rigid or semi-rigid. , whereas the proximal and distal regions 110 and 120 of the detachable balloon contain polymer layers, but no gold layers produced by electroforming or electroplating, are more flexible, and the polymer layers are Including PET, Nylon, Pebax or other polymers. The proximal region 110 is generally tapered terminating in a proximal neck 130 having a metal layer 90 made by electroforming or electroplating, or without a metal layer 90 made by electroforming or electroplating. It may have a shape. The distal region 120 generally terminates in a distal neck 140 having a metal layer 90 manufactured by electroforming or electroplating, or a distal neck 140 without a metal layer 90 manufactured by electroforming or electroplating. It may have a tapered shape. The partially metallized removable balloon is positioned between the proximal neck 130 and the proximal region 110 or the distal neck 140 and the distal region 120 at the proximal or distal "grooved" portion of the removable balloon. (fluted)" portion. In some embodiments, the grooved portion 150 may be metal-free or include a metal layer less than 1 μm thick, where the partially metallized polymer detachable balloon forms pleats. , when folded and mounted on the delivery system, act as a flexible "hinge" region to advance within the patient's body. In some embodiments, all or part of the grooved region may or may not comprise metal produced by electroforming or electroplating, or metal greater than 1 μm thick.

In some embodiments, the partially metallized polymer balloon in a pleated, folded configuration joined or operably connected to the first or second catheter 174 is made of a stiffer material (electroformed or electroformed). facilitating alternating regions of metal produced by plating or metal greater than 1 μm) and into the patient's body, including advancement over the guidewire 40, advancement through the guide catheter, and advancement through tortuous paths. To do so, a more flexible material (1 μm of flexible polymer alone or including flexible polymer containing metal with a thickness greater than . A detachable balloon with alternating flexible and rigid or semi-rigid regions 170 is strong enough to withstand compression, compaction or collapse after expansion in vivo, yet is flexible. It is pleated for movement through a narrow passageway, is sufficiently flexible when folded, and traverses the kinks and turns of the vasculature when coupled or operatively connected to a catheter or catheter assembly 5.

The wall thickness of the metallized portions of the polymer-only and partially metallized detachable balloon may be uniform, or each portion may have a different thickness. For example, the wall 30 of the metallization of the removable partially metallized polymer balloon 20 can be 3, 5, 10, 15, 20, regardless of material, including any value between 3 μm and 200 μm. , 30, 40, 50, 60, 70, 80, 90, 100 or 200 μm. Alternatively, the thickness of the metallized portion wall 30 of the removable partially metallized polymer balloon 20 at different locations along the removable balloon 10 may vary. The thickness may vary between each individual metallized region and each polymer only or non-metallized region. Wall thickness may vary within individual metallized regions and each polymer or non-metallized region, according to some embodiments. In some embodiments, the metallized portion of the removable partially metallized polymer balloon is 3-100 μm thick, including the metallized areas where the metal is deposited by electroplating or electroforming. There may be. In some embodiments, the polymer wall 30 or non-metallized portion of the removable partially metallized polymer balloon 20 may have a thickness in the range of about 3-60 μm. In some embodiments, a cross-sectional view of the wall 30 of the pleated, folded removable partially metallized polymer balloon 20 comprises polymer only, or one or more polymer layers and an electrical More preferably comprising one or more metal layers less than 1 μm thick sandwiched between harder regions 170 comprising metal layers 90 manufactured by plating or electroforming, or metal layers 90 greater than 1 μm thick. A flexible region 165 may be shown. In some embodiments of the removable partially metallized polymer balloon 20, the proximal neck 130 and proximal region 110 of the partially metallized polymer balloon 20 are manufactured by electroplating or electroforming. polymer layer 99 and metal layer 90, or a metal layer 90 having a thickness greater than 1 μm, while the distal region 120 includes polymer only, or polymer layer 99 and metal layer 90 having a thickness less than 1 μm. including.

In various embodiments, all or a portion of the exterior or interior surface of removable balloon 10, including polymeric balloon 12, metallized polymeric balloon 14, metallic balloon 16, and polymer-coated metallic balloon 18, is modified from hydrophobic to hydrophilic properties. may be coated by known means with a variety of materials having properties ranging from urethanes, other metals, or combinations thereof. Coatings can serve a variety of purposes, including improved biocompatibility, enhanced blood contact, surface texturing, or conformal coatings to improve part durability, from the polymer layer 99 to the metal layer 90 . including coatings that reduce the risk of delamination of

In some embodiments of the removable metallized polymer balloon 14, a metal wire or ribbon may be applied to all or part of the outer surface of the polymer balloon 12 or the polymer inner layer or base layer structure. Metal wires may be provided in various thicknesses and shapes. By way of example and not limitation, the metal wire may have a circular cross-section and a diameter ranging between 25 μm and 600 μm. In a preferred embodiment, the round metal wire has a diameter of about 50-200 μm. Alternatively, the metal wire may be provided as a flat ribbon or semi-flat "half round" wire. The width of the flat wire typically ranges from about 25 μm to about 600 μm in width and from about 20 μm to about 300 μm in thickness. In particular, the width of the flat ribbon wire is 25, 50, 75, 100, 125, 150, 175, 200, 225, 250, 275, 300, 325, 350, including any value between 25 μm and 600 μm. 375, 400, 425, 450, 475, 500, 525, 550, 575, or up to 600 μm. Similarly, the thickness of the flat ribbon protruding from the surface of the removable balloon is 20, 30, 40, 50, 60, 70, 80, 90, 100, including any value between 20 μm and 300 μm. 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, and 300 μm. Other wire shapes may be used, such as wires with non-linear or irregular cross-sectional profiles. The pitch and number of wire loops (loop density) and the angle of winding may vary both between and within embodiments. As such, the metal wire may be uniformly wound and arranged in some embodiments of the removable metallized balloon, while in other embodiments the pitch, number of loops, wrap angle, or You may change those combinations.

In some embodiments, after placing a metal wire or ribbon on the outer surface of the polymer balloon 12 or polymer inner or base layer 99 structure, the resulting metallized polymer balloon 14 is coated with a polymer or adhesive. In some embodiments, a coating comprising a urethane composition is used to further adhere the metal wire to the removable polymer balloon 12 or inner or base layer 99 structure. The urethane composition may be provided in concentrations ranging from 2% to 10% urethane in solvent. By way of example and not limitation, solvents may include tetrahydrofuran (“THF”) or oxolane. However, other solvents may be used. In one aspect, a solvent such as THF may chemically modify, react with, or bond to the surface of the removable polymer balloon 12 or inner or base layer 99 structure. Thus, a strong bond formation is formed between the urethane layer and the removable polymer balloon 12 or polymer inner layer or base layer 99 structure to further secure the wire to the outer surface of the removable balloon 10 . The urethane coating may be applied by any suitable method including, but not limited to, dip coating or spray coating. The preferred method results in a more even or even distribution of the urethane composition over and between the metal wires applied to the surface of the removable polymer balloon 12 or polymer inner layer or base layer 99 structure. A preferred method increases the force required to cause delamination of the metal wire from the removable balloon 10 . A preferred method reduces the risk of breaking or breaking the metal wire. A preferred method allows simultaneous coating of multiple metallized polymer balloons 14 . Using a preferred method, the coated metallized polymer balloon 14 may be manufactured at a reasonable cost.

In one embodiment, the removable polymeric balloon 12 or polymeric inner or base layer 99 structure is prepared in a manner similar to that of typical angioplasty balloons. For example, tubular polymeric material includes material that is cut to desired lengths to form distal neck 140 and proximal neck 130 at opposite ends of the balloon. One end of the balloon is glued to a tubular structure (eg, a blunt needle) that forms a leak-tight conduit to the interior of the balloon. The tubular structure also allows additional tubing to pass inside the balloon. This additional tube provides a means of inflating the balloon and also acts as a splint to secure the balloon during the manufacturing process. The additional tubing may engage a valve, such as a Luer valve, so that the balloon can be inflated and kept inflated during the process of adding metal. To complete the fabrication of the removable polymer balloon 12 or polymer inner layer or base layer 99 structure, the remaining necks or openings are filled and sealed. In one embodiment, the remaining opening is filled with an ultraviolet (UV) curable adhesive that is cured to seal the balloon. The removable polymer balloon 12 or polymer inner layer or base layer 99 structure is then pressurized or expanded and positioned in a device that can apply a wire to the surface of the removable polymer balloon 12 or polymer inner layer or base layer 99 structure. . Optionally, the pressurized removable polymer balloon 12 or polymer inner or base layer 99 structure may be coated with a urethane solution prior to applying the metal wire. In one embodiment, a device capable of applying a wire to the surface of the removable polymer balloon 12 or polymer inner layer or base layer 99 structure is wrapped like a lathe such that the attached balloon 10 rotates about its longitudinal axis. System. Once the balloon is attached, one end of the wire is glued to the polymer balloon 12 and the polymer balloon 12 is rotated. While the polymer balloon 12 is rotating, the wire is wrapped around the desired portion of the polymer balloon 12 with the desired pitch, loop density and angle. After wrapping, the wire ends are glued to the polymer balloon 12 . The wire-wrapped polymer balloon is removed from the wire-wrapped assembly and coated at least once with a urethane-based composition. In one embodiment, the entire wire-wrapped polymeric balloon may be coated with a urethane composition as described herein. In other embodiments, a mask may be placed over the wire-covered portion of the polymer balloon so that only the wrapped portion is coated. After the urethane coating has cured, the wire-wrapped polymer balloon may be depressurized (deflated), pleated, and folded. The pleated and folded detachable wire-wrapped polymeric balloon may be in a collapsed configuration or a delivery configuration.

(Manufacture of detachable balloon catheters - manufacture of detachable metal balloons and detachable polymer-coated balloons)
Hollow metallized expandable body 10 is manufactured by electroforming a metal such as gold onto a sacrificial mandrel 740 made from a conductive material such as aluminum. can do. Sacrificial mandrel 740 may then be removed from the interior of expandable body 10 by processes such as drilling and acid etching. The electroforming process can produce rounded, pebbled or grained structures on the outer surface of the expandable body. The metallized expandable body 10 may further undergo an annealing process to improve flexibility of the expandable body. In one embodiment, the gold expandable body 10 is heated to about 300° C. for about 1 hour and then immediately quenched in a room temperature distilled water bath. Finally, polymer coatings can be applied to the expandable body 10 to modify its mechanical, electrical or biocompatibility properties. Polymer coatings may include parylene, polyurethane, PTFE, silicone or other biocompatible polymers. Coatings may be applied by dipping, spinning, spraying or other deposition processes specific to the particular polymer. The coating may be applied to the entire exterior of the expandable body 10 or only to selected areas by masking areas to be uncoated.

(Manufacturing of Detachable Balloon Catheter - Pleated and Folded Detachable Balloon)
To facilitate advancement of the partially or fully metallized (or metallized) or partially or fully plated removable balloon through the vasculature, the removable balloon is , can be compressed into a variety of shapes and sizes as shown in FIGS. 83A-D and 84A-B. For example, partially or fully metallized or partially or fully plated removable balloons are pleated (or pleated), folded, and optionally three to Compressed to a diameter small enough to pass through a 9 Fr or larger guide catheter or be maneuvered through arteries, veins, atria (including atria and ventricles), other blood-containing structures, biological conduits or other biological spaces can be Pleats, folds, and optional compression can include a variety of forms and patterns. As shown in FIGS. 84A-B and 85, the number and length of pleats can be optimized for the expanded diameter and wall thickness of the removable balloon. For example, partially or fully metallized or partially or fully plated detachable balloons may be pleated to a diameter small enough to pass through a 3-8 Fr guide catheter or maneuver through a cerebral artery. , can be folded and compressed. Optionally, this compression may include various forms and patterns of pleats, folds or compressions.

In some embodiments, the detachable balloon of detachable balloon catheter 1 is configured to expand from a compressed or deflated configuration to an expanded configuration, wherein the detachable balloon is compressed or deflated. When in configuration, the walls 30 of the removable balloon 10 are oriented in a clockwise or first axial direction with respect to the first axis 706 to form a folded-over region of the removable balloon. It has a pleated configuration including a plurality of pleats folded in a counterclockwise direction with respect to 706 . In some embodiments, when the removable balloon of the removable balloon catheter 1 is in a compressed or deflated configuration, the walls 30 of the removable balloon 10 form folding regions of the removable balloon. In addition, the removable balloon is inflated in a pleated configuration including a plurality of pleats folded clockwise about the first axis 706 or counterclockwise about the first axis 706 . When in the folded configuration, the multiple pleats are not folded. In some embodiments, each pleat 742 of the plurality of pleats of the removable balloon of the removable balloon catheter 1 includes ridges extending proximal-distal and radially from the first axis 706 . In some embodiments, each pleat 742 includes ridges extending in a proximal-distal direction, and each pleat 742 of the plurality of pleats of the removable balloon of the removable balloon catheter 1 extends in a proximal-distal direction. It is separated from any immediately adjacent pleats 742 by a laterally extending insertion trough. In some embodiments, the pleated configuration of the pleated balloon of the removable balloon catheter 1 comprises an alternating ridge-trough arrangement. In some embodiments, each pleat 742 of the plurality of pleats of the pleated balloon of the removable balloon catheter 1 is oriented clockwise with respect to the first axis 706 or with respect to the first axis 706. It is folded over the immediately adjacent pleats 742 in a counterclockwise direction. In some embodiments, the detachable balloon of detachable balloon catheter 1 has been expanded by eliminating multiple pleats present in a substantially pleated configuration or a deflated or compressed configuration. configured to take configuration.

In some embodiments, the compressed or deflated detachable balloon of detachable balloon catheter 1 is filled with water, saline, radiocontrast, or a combination thereof in the central void of the detachable balloon (or It can be expanded by injecting the void 115 or internal volume. In some embodiments, the detachable balloon of the detachable balloon catheter 1 is capable of detachable pressure of less than 10 atmospheres, less than 5 atmospheres, less than 4 atmospheres, less than 3 atmospheres, less than 2 atmospheres, or less than 1 atmosphere. It is configured to expand from a compressed or deflated configuration to an expanded configuration by application to the central void 115 or interior volume of the. In some embodiments, the passage of fluid from the proximal hub of the first catheter 173 through the first lumen (or lumen) 162 to the central void 115 or interior volume of the removable balloon 10. The detachable balloon central void 115 or interior volume of the detachable balloon catheter 1 can be pressurized therein. In some embodiments, the removable balloon catheter 1 passes from the hub 179 of the first catheter 173 through the lumen 162 of the first catheter 173 to the central void 115 or interior volume of the removable balloon 10, It is configured to allow fluid to be injected from the central void 115 or interior volume of the removable balloon 10 at a rate faster than the leakage of fluid into spaces adjacent to the removable balloon 10 . In some embodiments, expansion of detachable balloon 10 of detachable balloon catheter 1 results in foreshortening of detachable balloon 10 along a plane parallel to first axis 706 .

Various methods are used to pleat, fold and compress the partially or fully metallized or partially or fully plated removable balloon so that it can be used in a variety of lumens. and conduits. These include, but are not limited to, guide catheter lumens, arteries 317, veins 318, atria (including atria and ventricles), other blood-containing structures, biological conduits 900 or other biological spaces 904.

In one embodiment, the partially or fully metallized or partially or fully plated detachable balloon is folded and partially or fully metallized or partially or fully plated. One or more pleats are formed before or after attaching the plated removable balloon to the first catheter 173, and the pleats are rolled like a non-compliant angioplasty balloon fold. compressed. In another embodiment, the partially or fully metallized or partially or fully plated removable balloon is flattened into a planar shape and rolled into a cylindrical shape. In certain embodiments, a partially or fully metallized or partially or fully plated detachable balloon may be folded and wrapped around the first catheter 173 .

For example, a partially or fully metallized or partially or fully plated removable balloon can be made with one or more pleats and then the pleats can be rolled into a cylinder. A partially or fully metallized or partially or fully plated removable balloon may be flattened into a flat shape and then rolled into a cylindrical shape. Alternatively, a partially or fully metallized or partially or fully plated detachable balloon may be compressed into a compact spherical shape. Additionally, portions of the partially or fully metallized or partially or fully plated removable balloon may be twisted or braided during compression. In certain instances, a partially or fully metallized or partially or fully plated removable balloon may be compressed around the first catheter 173 . In other embodiments, a partially or fully metallized or partially or fully plated removable balloon may be compressed on its own without a central mandrel containing a catheter mandrel.

In another embodiment, a partially or fully metallized or partially or fully plated removable balloon is pleated and then the pleats are wrapped around the hollow cylindrical member of the first catheter 173. The partially or fully metallized or partially or fully plated removable balloon 14 or 20 is compressed against the first catheter 173 . In another embodiment, the partially or fully metallized or partially or fully plated removable balloon 14 or 20 is pleated and then wrapped around a wire mandrel where the pleats are removable. The partially or fully metallized or partially or fully plated removable balloon 14 or 20 is then compressed against a removable wire mandrel. In another embodiment, a partially or fully metallized or partially or fully plated removable balloon 14 or 20 is pleated, and then a removable balloon 14 or 20 that serves as a central fixation point or mandrel is formed. The pleats are rolled into a generally cylindrical shape without wires or catheters.

In various embodiments, a partially or fully metallized or partially or fully plated removable balloon is attached to the first catheter 173 and then pleated and then pleated to the first catheter 173 . It is folded, wrapped or compressed onto the catheter 173 . In another embodiment, a partially or fully metallized or partially or fully plated removable balloon is first pleated and attached to the first catheter 173, after which the pleats are attached to the first catheter. It is wrapped or compressed around the outer surface of catheter 173 .

In some embodiments, removable balloon inner or base layer structures or partially or fully metallized or partially or fully plated pleats prior to forming pleats and removable Excess material may be removed from one or both ends of the balloon, proximal end of proximal neck 130 or distal end of distal neck 140 . Excess material can be removed by cutting the neck. Cutting is by rotating the inner layer or base layer structure of the removable balloon or the partially or fully metallized or partially or fully plated removable balloon under a fixed blade, or The blades are applied to the inner layer or base layer structure of the removable balloon, or the proximal neck 130 or distal portion of the partially or fully metallized or partially or fully plated removable balloon 14 or 20 . This can be accomplished by rolling on neck 140 . In some instances, heat may be used to soften the neck or neck edges prior to cutting. Those skilled in the art are skilled in the art to remove removable balloon inner or base layer structures, or excess material at the neck end of removable balloons that are partially or fully metallized or partially or fully plated. will recognize by methods well known in the art.

The partially or fully metallized or partially or fully plated removable balloon is pleated before or after removing excess material from the proximal neck 130 or distal neck 140; It may be mounted on a folded mandrel. In this regard, as part of a custom packaging system, a partially or fully metallized or partially or fully plated removable balloon pre-mounted needle hub replaces the mandrel. be done. To keep the mandrel 740 stationary during shipping, the mandrel 740 and the partially or fully metallized or partially or fully plated detachable balloon are placed in a shipping tube (or shipping tube). A stopper or other stabilizing means can be placed at the tip of the mandrel 740 when it is positioned in the . The stopper may be a piece of foam or other material known in the art. The pleated and folded mandrel 740 reduces the risk of compression of partially or fully metallized or partially or fully plated removable balloons during shipping and set-up and reduces the risk of pleat formation. , to prevent excessive compression of partially or fully metallized or partially or fully plated detachable balloons during folding and compression. This reduces the outer diameter of mandrel 740 to the outer diameter of second catheter 174, including but not limited to those disclosed in co-filed PCT applications PCT/US2014/030869 and PCT/US2015/050783; This is accomplished by sizing the desired final inner diameter to correspond to the outer diameter of the telescoping segment 185 that will be used during assembly of the complete medical device 1, commonly referred to as the Blockstent Microcatheter device and the Ballstent Microcatheter device.

Once the partially or fully metallized or partially or fully plated removable balloon 741 and mandrel 740 are placed within the transport tube with the stabilizing means, the transport tube is shipped to a third party, The partially or fully metallized or partially or fully plated removable balloon is then removed and pleated. As shown in FIGS. 77-79, the pleated, partially or fully metallized, or partially or fully plated removable balloon may have a plurality of pleats. In a preferred embodiment, the pleated, partially or fully metallized, or partially or fully plated removable balloon may have three pleats. In some examples, the pleated, partially or fully metallized, or partially or fully plated removable balloon has only one pleat 742, or as many as ten pleats. can. Those skilled in the art will appreciate that partially or fully metallized or partially or fully plated removable balloons It has the number of pleats necessary to compress a partially or fully metallized or partially or fully plated detachable balloon to a size that allows it to be advanced through the vasculature using a delivery system. you will recognize what you can do.

In some embodiments, partially or fully metallized or partially or fully plated detachable balloons may form pleats without heating of the head. In some embodiments, partially or fully metallized or partially or fully plated removable balloons form pleats without extending the residence time of the pleat heads. can be advantageous. Pleats on a partially or fully metallized or partially or fully plated detachable balloon without heating the head and without extending the residence time of the pleat head. By forming a partially or fully metallized or partially or fully plated detachable balloon can be expanded without permanent collapse. A partially or fully metallized or partially or fully plated removable balloon 741 may be folded onto the mandrel 740 while in the fold-head. In some embodiments, a partially or fully metallized or partially or fully plated removable balloon may be pleated and removed from the mandrel 740 . After the partially or fully metallized or partially or fully plated detachable balloons are pleated and folded, they are packaged for shipment and the pleat and folding information is included on the package. recorded in a recording tube.

Forming pleats is accomplished by compressing a partially or fully metallized or partially or fully plated detachable balloon between two or more pleats. This compression achieves a single or multiple lobular shape of the partially or fully metallized or partially or fully plated detachable balloon. These lobes are then unidirectionally folded around the central axis of a partially or fully metallized or partially or fully plated removable balloon, thereby partially or fully A fully metallized or partially or fully plated removable balloon is formed into a tubular shape concentric with its ends and approximating the dimensions of one or both ends.

(Detachable Balloon Catheter—Manufacturing of Detachable Balloon Catheter Assembly Partially or fully metallized or partially or fully plated detachable balloons can be manufactured using a variety of materials, components, systems and methods. may be used to attach to the delivery system, first catheter 173 or second catheter 174. Partially or fully metallized or partially or fully plated removable balloons may be attached to the second catheter 173. The size and shape of the distal end of one catheter 173 and the size and shape of the opening in the wall 30 of the partially or fully metallized or partially or fully plated removable balloon 14 or 20. are fitted to form a friction fit 202 between the first catheter 173 and the partially or fully metallized or partially or fully plated removable balloon 14 or 20. As such, it may be attached to the first catheter 173. In one embodiment of the friction fit 202, an elastic sleeve or wrap 204 is placed within the proximal neck 130 of the removable balloon 10, generally indicated as 206. Attached, the sleeve can engage the first catheter 173. Alternatively, the elastic sleeve or wrap 204 can be partially or fully metallized or partially or fully plated removable balloon 14. or 20 placed around the proximal neck 130 and holding together the partially or fully metallized or partially or fully plated removable balloon 14 or 20 and the first catheter 173 In another embodiment of the friction fit 173, a partially or fully metallized or partially or fully plated removable balloon 14 or 20 may be attached with an adhesive or glue. , or using welding or soldering to attach to the first catheter 173. A partially or fully metallized or partially or fully plated removable balloon 14 or 20 may be partially or fully plated. A fully metallized or partially or fully plated removable balloon 14 or 20 and first catheter 173 may be attached to a releasable clamp or a wire, polymer strand, filament, thread that can be loosened or removed. Or attach mechanical parts such as strings (fitti ng) can be attached to the first catheter 173 .

The method also includes partially or fully metallizing or partially or fully plating all or part of the proximal neck 130 or distal neck 140 segments of the removable balloon 14 or 20 . or welding or joining segments of both the proximal neck 130 and the distal neck 140 . In other embodiments, the proximal neck segment 130, the distal neck segment 140, or both the proximal neck segment 130 and the distal neck segment 140 are joined during the electroforming process to partially or completely Removable balloons 14 or 20 can be formed with solid metallization, or partially or fully plated.

(elongated extendable body)
The present disclosure relates to a medical device 1 that includes an elongated or expandable body 720. These devices are also referred to herein as "second medical devices." As used herein, elongated body 720 is a long, thin, flexible structure that can be pushed or carried through the lumen of a catheter and implanted within a patient. Elongated body 720 occupies space and can form complex shapes, but does not expand during or after deployment. As used herein, expandable body 720 is a long, thin, flexible structure that can be constrained, deflated, compressed, or pleated to accommodate the catheter in a collapsed configuration. A portion of the expandable body 720 can be pushed or carried through the lumen of the body, can be implanted within a patient, and can expand in size during or after deployment. An elongated expandable body 720 that can be used with the removable balloon catheter 1 is described.

As shown in FIG. 86, the first elongated or expandable body 10 of the second medical device 1 can be used to treat saccular aneurysms, arteries, veins, LAAs, valves, etc. A second medical device via a separable bond or bond after placement within the ambient leak, blood-containing space, biological conduit 900 or space, or central cavity 115 or interior volume of the expanded removable balloon of the first medical device. It is joined to the second elongated body of device 1 . The first elongated or expandable body 10 of the second medical device 1 is joined to the second elongated body of the second medical device 1 and distal to the second catheter 174 of the first medical device 1 . After ejecting the first elongated or expandable body 10 of the second medical device 1 from the end, the second elongated body of the second medical device 721 is removed from the first elongated body 720 of the second medical device 700 . It can be separated and the second elongated body 721 can be removed from the patient while the first elongated or expandable body 720 remains within the patient. In some embodiments, first elongated or expandable body 720 acts to stimulate thrombus formation and fibrosis in aneurysm lumen or sac 722 .

The first elongated body or coil may include a primary wire having a diameter of 0.00175-0.003 inches. This primary wire may be wound on itself to provide a coil overall or secondary diameter of 0.010 to 0.040 inches in diameter. Further, this secondary shape of the first elongated body or coil may be formed into a tertiary shape having a diameter of approximately 2-100 mm or 0.1-4 inches.

Standard nominal values for guidewire 40 diameters (and their associated coil sizes) are 0.014 inches, 0.018 inches, and 0.035 inches/0.038 inches. FIG. 91 shows the minimum and maximum diameters of the second various catheters 173 (or guidewire shafts), first elongated bodies 720 (or coils), and second elongated bodies 721 (or pusher wires). , summarizes embodiments of the first medical device 1 and the second medical device 700 corresponding to these three guidewire platforms. Figure 90 summarizes the minimum and maximum lengths of these elements. Figures 87-89 detail the nominal dimensions of these elements and the ranges of acceptable and recommended dimensions.

In various embodiments, the first elongated body or coil is not provided with a tertiary shape, but is an elongated straight but flexible second body that can have a length of between about 10 cm and about 400 cm. 1 elongated body or coil. A straight first elongated body or coil may be deployed within the aneurysm and within the removable balloon, or the first elongated body or coil extends through both the aneurysm and the removable balloon. may The straight flexible first elongated body or coil can be used with a variety of balloons of any size and shape. In one aspect, a first elongated body or coil is formed into a secondary shape by an expanded removable balloon. The balloon imparts an ideal secondary shape to the first elongate body or coil by constraining them within the balloon.

A straight coil is desirable to reduce friction during passage through various catheters and/or delivery devices. A long straight first elongated body or coil also allows the use of only a single first elongated body or coil for each balloon. When treating an aneurysm with a single removable balloon and one first elongated body or coil, the user has the flexibility (or adaptability) to reposition the balloon and first elongated body or coil during treatment. : flexibility) is improved. The combination of a single removable balloon and first elongated body or coil also reduces overall treatment time.

In various aspects, the first elongated body or coil can be manufactured to include one or more distal loops. The loops can deform under tension for delivery through one or more catheters and return to their natural loop shape as they exit the catheter. Also, the loops on the elongated straight first elongated body or coil may cause spearing or puncturing that may occur when using a first elongated body or coil without loops. protects the posterior wall of the aneurysm 320 from In various other embodiments, the first elongate body or coil may include 1, 2, 3, 4, 4 or more end loops, or no end loops. A second elongated body, a pusher wire, which joins or contacts the proximal end of the first elongated body or coil so that the first elongated body or coil remains in a desired position. Or it can be advanced and deployed by a pusher catheter. Similarly, for embolization of peripheral arteries or veins, a low-friction straight first elongated body or coil with 0, 1, 2, 3 or 4 loops on the distal end can be used for single Allows for the use of a first elongated body or coil that facilitates occlude the distal neck opening of the balloon with the first elongated body or coil to reduce blood flow through the balloon. The first elongated body or coil has one loop outside the removable balloon while another loop is positioned within the neck or within the central void of the removable balloon. can be arranged to be located at

In some methods, the operator gently (or gently) pushes the first loop out of the second catheter 174 to occlude the opening in the distal neck of the balloon and the tip of the second catheter 174. It can be pulled back into the central void of the balloon and then the rest of the first elongated body or coil within the balloon deployed. At this point, the operator may release any remaining tension in the delivery system and acquire an angiogram to confirm complete occlusion. If the removable balloon or first elongated body or coil is not sized or positioned properly, then the first elongated body or coil can be removed or repositioned, and the removable balloon deflated and repositioned, removed, or replaced. The first elongated body or coil can be reinserted or a new first elongated body or coil can be inserted. When the operator is satisfied with the placement of the removable balloon and first elongated body or coil, the operator removes the first elongated body or coil and the expanded balloon and removes the first catheter 173 and second elongated body. 721 can be removed.

In some methods, the operator gradually pushes the distal loop of the first elongated body or coil out of the second catheter 174 to construct the aneurysm sac 722 and then the number of first elongated bodies or coils. That straight portion is pushed into the aneurysm sac behind or adjacent to the dilatation balloon, after which the tip of the second catheter 174 is pulled back into the central void 115 of the balloon 10 and the remainder of the first elongated body or coil is pulled. can be deployed within the balloon. At this point, the operator may release any remaining tension in the delivery system and acquire an angiogram to confirm complete occlusion. If the removable balloon or first elongated body or coil is not sized or positioned appropriately, then the first elongated body or coil can be removed or repositioned, deflating the removable balloon and repositioning; It can be removed or replaced, the first elongated body or coil can be reinserted, or a new first elongated body or coil can be inserted. When the operator is satisfied with the placement of the removable balloon and first elongated body or coil, the operator removes the first elongated body or coil and the expanded balloon and removes the first catheter 173 and second elongated body 721 . can be removed.

In various embodiments, as shown in FIG. 93F, first elongated body or coil 720 can be manufactured to include one or more distal loops 702 and one or more proximal loops. The loops can deform under tension for delivery through one or more catheters and return to their natural loop shape as they exit the catheter. Distal loop 702 is pushed forward such that it presents a flat surface against adjacent tissue or balloon wall 30 like first elongated body or coil 720 to reduce the risk of wall puncture. can be configured to reduce The proximal loop can be configured to present a shape that is more easily grasped by the snare catheter. For example, when a first elongated body or coil having both a distal loop and a proximal loop is placed within the central void of an expanded removable balloon within a blood vessel, the distal loop 702 is positioned distally of the balloon. The expanded balloon 10 can be placed in the distal vessel lumen to fill at least a portion of the opening in the neck 140, the central portion of the first elongated body or coil 720 being expanded and removable. It can be placed in the central void 115 of the possible balloon. The first catheter 173 can then be removed from the proximal neck 130 of the expanded removable balloon 10 . The proximal loop can then be placed in the vessel lumen proximal to the expanded balloon 10 . In embodiments where first elongate body or coil 720 is joined to second elongate body 721 , first elongate body or coil 720 can then be removed from second elongate body 721 . After removal of the expanded removable balloon 10 and the first elongated body or coil 720, in situations where placement of the removable balloon 10 is determined to be undesirable, the first removable balloon 10 may be removed using a snare catheter. The proximal loop or loops of elongated body or coil 720 can be grasped and the first elongated body or coil 720 can be removed from the patient. A snare catheter can then be used to grasp the proximal neck 130 of the expanded, detached balloon 10, and the balloon 10 is deflated by drawing it into a guide catheter or sheath and removed from the patient. can be removed.

In some embodiments, the removable balloon 10 and single first elongated body or coil combination 720 is a full wide-necked bifurcation aneurysm having a width of 12 mm and a height of less than 10 mm. aneurysm) can be used to completely occlude the aneurysm. In one aspect, one or more first elongate bodies or coils 720 can be provided in a kit. The kit may include a first elongated body or coil 720 ranging from approximately 10 cm to 400 cm. For example, without limitation, a single kit may contain , about There may be from 1 to 30 first elongated bodies or coils.

When treating a patient using a removable balloon and a single first elongated body or coil, the length of the first elongated body or coil used may be an aneurysm, a removable balloon or both. can be determined by the desired coil packing density of As used herein, fill density refers to the percentage of the cavity defined by the aneurysm, removable balloon, or both that is filled by the first elongated body or coil. In various embodiments, the packing density is about 5% to 75% (eg, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55% %, 60%, 65%, 70%), or 75%) packing density).

In some embodiments, the second medical device 700 includes a first elongated or expandable body 720 connected to the lumen 163 of the second catheter 174 of the first medical device including the detachable balloon catheter 1 . to a human patient joined to a second elongated body 721 configured to push or carry into and pull or carry the first elongated or expandable body 720 out of the lumen 163 of the second catheter 174. includes a first elongated or expandable body 720 configured for permanent implantation of the . First elongated body 720 and second elongated body 721 are configured to pass through lumen 163 of second catheter 174 and enter a human patient in an elongated form. In some embodiments, the second medical device 700 is expandable to push or carry an expandable body 720 into and out of the lumen 163 of the second catheter 174. An expandable body 720 configured for permanent implantation in a human patient is joined to a second elongated body 721 configured to pull or carry the body 720 . Expandable body 720 is configured to pass through lumen 163 of second catheter 174 and into a human patient in an elongated, constrained, compressed, or deflated configuration. be.

In some embodiments, at least a portion of the first elongated or expandable body 720 is configured for implantation into the central void 115 or interior volume of the removable balloon 10 of the first medical device 1. be. In all embodiments, the first elongated or expandable body 720 can be separated from the second elongated body 721 , which separates the first or expandable elongated body 720 . It can be removed from the lumen 163 of the second catheter 174 while remaining in place on the patient. In some embodiments, the second elongated body 720 can be a wire, coiled wire, catheter or laser cut tube comprising Nitinol. In some embodiments of the second medical device 700 in which the second elongated body is a catheter or laser cut tube comprising Nitinol, at least a portion of the first elongated body 720 is Within the lumen of a catheter or laser-cut tube containing Nitinol.

The elongated body may be made from wires, polymers, and other flexible materials, and combinations thereof. The elongate body is generally not formed from a self-expanding material, nor is the elongate body generally configured to self-expand. Examples of elongated bodies include coils, metal coils, coils containing metals, polymer coils, coils containing metals and polymers, coiled wires, coiled metal wires, wires containing coiled metals, metals and polymers. Coiled wire, strand, polymer strand, metal strand, metal containing strand, polymer and metal containing strand, vascular coil, wire assembly, metal wire assembly, metal containing wire assembly, polymer strand assembly, metal and polymer containing wire or strand assembly, coiled wire assembly, coiled metal wire assembly, coiled metal containing wire assembly, coiled polymeric strand assembly, coiled structural assembly containing metal and wire , assembly of strands, assembly of polymer strands, assembly of metal strands, assembly of strands containing metal, and assembly of strands containing polymer and metal, assembly of braided wire, assembly of braided metal wire, assembly of wire containing braided metal , braided wire assembly comprising metal and polymer, braided strand assembly, braided polymer strand assembly, braided strand assembly comprising polymer and metal, woven wire assembly, woven metal wire assembly, woven metal wire assembly , woven wire assemblies comprising metal and polymer, woven strand assemblies, woven polymer strand assemblies, and woven strand assemblies comprising polymer and metal, and combinations thereof.

The expandable body may be made from wires, polymers, and other flexible materials, and combinations thereof. The expandable body is generally formed from a self-expanding material or is generally formed such that the expandable body 10 is self-expanding. Examples of expandable bodies include self-expanding wires, nitinol wires, assemblies of wires, assemblies of metal wires, assemblies of wires including metal, assemblies of polymer strands, assemblies of wires or strands including metal and polymer, coiled assembly of wire, assembly of coiled metal wire, assembly of wire including coiled metal, assembly of coiled polymer strand, assembly of coiled structure including metal and wire, assembly of strand, assembly of polymer strand, Metal strand assembly, metal-containing strand assembly, and polymer and metal-containing strand assembly, braided wire assembly, braided metal wire assembly, braided metal-containing wire assembly, metal and polymer-containing braided wire assembly , braided strand assembly, braided polymer strand assembly, braided strand assembly including polymer and metal, woven wire assembly, woven metal wire assembly, woven metal wire assembly, woven wire assembly including metal and polymer , woven strand assemblies, woven polymer strand assemblies, woven strand assemblies comprising polymers and metals, balloons, and combinations thereof.

In some embodiments, the expandable body wire, strand, coil, coiled wire, wire assembly, strand assembly, coil assembly, coiled wire assembly, wire woven assembly, The strand fabric assembly, coil fabric assembly, coiled wire assembly, wire braid assembly, strand braid assembly, coil braid assembly, coiled wire braid assembly and combinations thereof are self-expanding. In some embodiments, the expandable body wire, strand, coil, coiled wire, wire assembly, coil assembly, coiled wire assembly, woven wire assembly, woven coil assembly, coiled wire woven assemblies, wire braid assemblies, coil braid assemblies, coiled wire braid assemblies and combinations thereof comprising nitinol.

In some embodiments, the first elongated or expandable body 10 of the second medical device 1 comprises a coiled wire, the coiled wire having a primary diameter of 0.00175 to 0.00175 mm diameter. .003 inches and the secondary diameter of the coiled wire is 0.010-0.050 inches in diameter. In some embodiments, the first elongated or expandable body 10 has a tertiary structure with no pre-formed loops or shapes and, when relaxed, , configured to form a straight or amorphous tertiary shape, or configured as a straight vascular coil. In some embodiments, at least a portion of first elongate body or expandable body 10 has a spiral, spherical or complex tertiary structure. In some embodiments, at least a portion of the first elongate body or expandable body 10 is configured to form a coiled, spiral or complex tertiary shape when relaxed. In some embodiments, the coiled wire is a vascular coil. In some embodiments, the distal portion of the first elongated or expandable body 10 comprises one loop of tertiary structure, and the remainder of the first elongated or expandable body 10 is stretched when relaxed. tertiary structure without pre-formed loops or shapes; Including one loop, the remainder of the first elongate body or expandable body 10 includes a tertiary structure configured to form a linear or undefined tertiary shape upon relaxation. In some embodiments, the distal portion of the first elongated or expandable body 10 includes two loops of tertiary structure, and the remainder of the first elongated or expandable body 10, when relaxed, A tertiary structure having no pre-formed loops or shapes, or the distal portion of the first elongated or expandable body 10 includes two tertiary structure loops, the first elongated body or The remainder of expandable body 10 includes a tertiary structure configured to form a linear or undefined tertiary shape upon relaxation. In some embodiments, the distal portion of the first elongated or expandable body 10 includes three tertiary structural loops, and the remainder of the first elongated or expandable body 10, when relaxed, The first elongated or expandable body 10 comprises three tertiary structural loops, comprising preformed loops or tertiary structures with no shape, or the first elongated or expandable body 10 The remainder of the contains a tertiary structure configured to form a linear or amorphous tertiary shape upon relaxation. In some embodiments, the distal portion of the first elongated or expandable body 10 comprises four or more tertiary structural loops when relaxed, and the rest of the first elongated or expandable body 10 contains pre-formed loops or tertiary structures that have no shape when relaxed, or the first elongate body or expandable body 10 contains four tertiary structure loops and the first elongate or The remainder of expandable body 10 includes a tertiary structure configured to form a linear or undefined tertiary shape when relaxed. The tertiary diameter of the looped, coiled, shaped, or tertiary portion of the first elongated or expandable body 10 can be 2-100 mm. In some embodiments, first elongate body or expandable body 10 comprises platinum, iridium, nickel, tungsten, or combinations thereof.

In some embodiments, first elongated or expandable body 10 of second medical device 1 is a wire having a primary diameter of 0.005-0.050 inches. In some embodiments, the first elongate body or expandable body 10 is a wire with no secondary or tertiary diameters or shapes. In some embodiments, the first elongate body or expandable body 10 is a wire and has no pre-formed loops or shapes. In some embodiments, first elongated or expandable body 10 is a wire and is configured to form a straight or unshaped tertiary shape when relaxed. In some embodiments, first elongated or expandable body 10 is a straight vascular coil. In some embodiments, first elongated or expandable body 10 is a wire and at least a portion of first elongated or expandable body 10 has a spiral, spherical, or complex tertiary structure. . In some embodiments, first elongated or expandable body 10 is a wire, a portion of first elongated or expandable body 10 has a spiral, spherical, or complex tertiary structure, The remainder of the first elongated or expandable body 10 comprises a tertiary structure that has no pre-formed loops or shapes when relaxed. In some embodiments, the first elongated or expandable body 10 is a wire, the distal portion of the first elongated or expandable body 10 comprises one loop of tertiary structure, the first elongated or the remainder of the expandable body is configured to form a straight or unshaped tertiary shape when relaxed; or the distal portion of the first elongated or expandable body is one of the tertiary structures. The remainder of the first elongated or expandable body, including the loops, includes pre-formed loops or shapeless tertiary structures when relaxed. In some embodiments, the first elongated or expandable body is a wire, the distal portion of the first elongated or expandable body comprises two loops of tertiary structure, and the first elongated or expandable body is a wire. possible the remainder of the body comprises pre-formed loops or shapeless tertiary structures when relaxed, or the distal portion of the first elongated or expandable body comprises two loops of tertiary structure; The remainder of the first elongated or expandable body includes a tertiary structure configured to form a straight or unformed tertiary shape when relaxed. In some embodiments, the first elongated or expandable body is a wire and the distal portion of the first elongated or expandable body comprises three loops of tertiary structure, and when relaxed, the first elongated or expandable body the remainder of the elongated or expandable body comprises a pre-formed loop-free tertiary structure, or the distal portion of the first elongated or expandable body comprises three loops of tertiary structure; A remaining portion of the first elongated or expandable body includes a tertiary structure configured to form a straight or unshaped tertiary shape when relaxed. In some embodiments, the first elongated or expandable body is a wire and the distal portion of the first elongated or expandable body 10 has a straight or undetermined tertiary shape when relaxed. or the distal portion of the first elongated or expandable body 10 comprises one loop of the tertiary structure and the first elongated or expandable body 10 The rest of the protein contains preformed loops or unshaped tertiary structures when relaxed. In some embodiments, the first elongated or expandable body 10 is a wire, the distal portion of the first elongated or expandable body 10 includes two loops of tertiary structure, the first The remainder of the elongated or expandable body 10, when relaxed, comprises pre-formed loops or shapeless tertiary structures, or the distal portion of the first elongated or expandable body 10 is free of tertiary structures. Including two loops, the remainder of the first elongated or expandable body 10 includes a tertiary structure configured to form a linear or undefined tertiary shape when relaxed. In some embodiments, the first elongated or expandable body 10 is a wire and the distal portion of the first elongated or expandable body 10 comprises three loops of tertiary structure, the first The remainder of the elongated or expandable body 10, when relaxed, comprises pre-formed loops or shapeless tertiary structures, or the distal portion of the first elongated or expandable body 10 has three tertiary structures. The remainder of the first elongated or expandable body 10 includes a tertiary structure configured to form a linear or undefined tertiary shape upon relaxation. In some embodiments, the first elongated or expandable body 10 is a wire, the distal portion of the first elongated or expandable body 10 comprises four or more loops of tertiary structure, and the The remainder of one elongated or expandable body 10 includes pre-formed loops or shapeless tertiary structures when relaxed, or the distal portion of the first elongated or expandable body 10 has a tertiary structure. Including four loops of structure, the remainder of the first elongated or expandable body 10 includes a tertiary structure configured to form a linear or undefined tertiary shape when relaxed. In some embodiments, the first elongated or expandable body 10 is a wire and the looped, coiled or formed portion of the first elongated or expandable body 10 has a tertiary diameter of 2 mm. ~100 mm. In some embodiments, the first elongated or expandable body 10 is a wire comprising Nitinol, where the Nitinol wire is plated or coated with platinum or gold, or is exposed to fluoroscopy (or fluoroscopy). ) is a nitinol wire further comprising one or more radiopaque markers that are visible, the radiopaque markers comprising platinum, iridium, gold, tungsten, or combinations thereof; A radiopaque marker in the form of a ring or band around the part.

In some embodiments, the second medical device 1 is configured to be carried by the catheter of the second medical device 700 through the lumen 163 of the second catheter 174 of the removable balloon catheter 1. It includes a first elongated body or expandable body 10 that is fitted. In some embodiments, the catheter of the second medical device 700 emits radiation that is visible during fluoroscopy, including where the radiopaque marker comprises platinum, iridium, gold, tungsten, or combinations thereof. Includes impermeable marker band 612 .

In some embodiments, first elongated body 720 of second medical device 720 comprises a wire assembly, coiled wire assembly, braided wire assembly, woven wire assembly, or other expandable body 720 . In some embodiments, the expandable body 720 of the second medical device 700 comprises a wire assembly, a coiled wire assembly, a braided wire assembly, a woven wire assembly, or other expandable body 720. In some embodiments, the first expandable body 720 of the second medical device 700 comprises a self-expanding wire assembly, a coiled wire assembly, a braided wire assembly, a woven wire assembly or other expandable body 720. include. In some embodiments, the expandable body 720 of a wire assembly, coiled wire assembly, braided wire assembly or woven wire assembly is generally cylindrical when not in a compressed, deflated, constrained or elongated configuration. is configured to be formed in the shape of In some embodiments, the expandable body 720 of a wire assembly, coiled wire assembly, braided wire assembly or woven wire assembly is generally cylindrical when not in a compressed, deflated, constrained or elongated configuration. is configured to be formed in the shape of In some embodiments, the expandable body 720 of the wire assembly, coiled wire assembly, braided wire assembly or woven wire assembly has a length of 2-100 mm when not in a compressed, deflated, constrained or elongated configuration. configured to form a general shape and size with a maximum diameter of In some embodiments, the expandable body 720 of the second medical device 700 comprises nitinol, nitinol wire, or nitinol wire plated or coated with platinum or gold. In some embodiments, the Nitinol wire expandable body 720 is visible during fluoroscopy, including when the radiopaque marker comprises platinum, iridium, gold, tungsten, or combinations thereof. Further comprising one or more radiopaque markers.

In some embodiments, the first elongated or expandable body 10 of the second medical device 1 comprises polymer strands or polymer strands plated or coated with platinum or platinum or gold. In some embodiments, the polymer strand portion of first elongated or expandable body 10 of second medical device 1 includes radiopaque markers comprised of platinum, iridium, gold, tungsten, or combinations thereof. , further comprising one or more radiopaque markers visible under fluoroscopy, including a ring or band of radiopaque markers around a portion of the polymer strand.

In some embodiments, the first elongated or expandable body 10 is 10-400 cm long, 70-400 cm long, or 10-70 cm long. In some embodiments, the first elongated or expandable body 10 has a lubricious or hydrophilic layer or coating, a Serene® coating sold by SurModics, Inc., or a coating sold by BioInteractions, Inc. Includes Assist® Coatings. In some embodiments, first elongated or expandable body 10 includes an outer layer comprising a lubricious outer layer, a PTFE outer layer, a polyimide outer layer, or a composite of PTFE and polyimide. In some embodiments, the second elongated body of the second medical device 1 includes a lubricious or hydrophilic layer or coating, a Serene® coating sold by SurModics, Inc., or a Serene® coating sold by BioInteractions, Inc. Includes Assist® Coating. In some embodiments, the second elongated body of the second medical device 1 includes an outer layer comprising a PTFE outer layer, a polyimide outer layer, or a composite of PTFE and polyimide. In some embodiments, the second elongated body of the second medical device 1 is a first elongated or expandable body that is pushed distally against the distal tip of the second catheter 174 by the user. Includes visual or tactile markings that allow the length of body 10 to be determined.

In some embodiments, the first elongated or expandable body 10 of the second medical device 1 and the second elongated body of the second medical device 1 are configured to separate by mechanical means. . In some embodiments, the first elongated body 10 of the second medical device 1 and the second elongated body of the second medical device 1 are configured to separate by electrolysis or corrosion. In some embodiments, the first elongated or expandable body 10 of the second medical device 1 and the second elongated body of the second medical device 1 are the same as the first elongated or expandable body 10. configured to separate at a region between a second elongated body sensitive to electrolysis or corrosion, or comprising first elongated or expandable body 10 and stainless steel; It is configured to separate at a region between the second elongated body. In some embodiments, the second elongated body of the second medical device 1 is configured to allow passage of electrical current from the proximal portion of the second elongated body to the electrolysis or corrosion sensitive area. Configured. In some embodiments, at least part of the second elongated body of the second medical device 1 is configured to allow passage of direct current. In some embodiments, at least part of the second elongated body of the second medical device 1 is covered with a material that insulates it from electrical conduction. In some embodiments, at least a portion of the segment sensitive to electrolysis or corrosion or configured for dissolution by electrolysis is not covered with a substance that insulates it from electrical conduction. In some embodiments, the first elongated or expandable body 10 of the second medical device 1 and the second elongated body of the second medical device 1 are configured to separate by electrothermal methods. In some embodiments, the separation occurs in a region between the first elongated or expandable body 10 and the second elongated body that can be melted by heating. In some embodiments, the second medical device 1 comprises a first elongated or expandable body 10 and a second elongated body that can be melted by heating from a proximal portion of the second elongated body. is configured to allow the passage of electrical current to the resistive heating element on or near the area between. In some embodiments, at least part of the second elongated body of the second medical device 1 is covered with a material that insulates it from electrical conduction.
In some embodiments, the first elongated or expandable body 10 of the second medical device 1 and the second elongated body of the second medical device 1 are not joined and the second elongated body of the second medical device 1 is not joined. The two elongated bodies are configured to push the first elongated or expandable body 10 through the lumen of the second catheter 174 of the first medical device 1 . In some embodiments, second elongated body 721 of second medical device 700 extends from the distal end of lumen 163 of second catheter 174 of first medical device 1 to second medical device 700 . Configured to eject first elongated or expandable body 720 . In some embodiments, the second elongated body 721 of the second medical device 700 extends from the distal end of the lumen 163 of the second catheter 174 of the first medical device 1 to the second elongated body 721 of the second medical device 700 . After ejection, one elongated or expanded body 720 can be removed from the lumen 163 of the second catheter 174 of the first medical device 1 .

In some examples, beads, balls, microspheres, bioabsorbable materials, glues, glues, solidified polymers, solidified foams, or combinations thereof are passed from the proximal end of the second catheter 174 to the second catheter. The lumen 163 of the catheter 174 is passed through the central void 115 or interior volume of the removable balloon 10 of the removable balloon catheter 1 to help maintain the expanded size and shape of the detached balloon 10 . .

(guide wire)
Lumen 163 of second catheter 174 has diameters of 0.010, 0.011, 0.012, 0.013, 0.014, 0.015, 0.016, 0.017, 0.018, 0. It can be configured to accept a guidewire 40 having a diameter of 0.010 to 0.038 inches, including 0.033, 0.034, 0.035, 0.036, 0.037 or 0.038 inch guidewires. can. Lumen 163 of second catheter 174 may be configured to receive guidewire 40 having a length of 50-500 cm or 200-400 cm.

(System including a first medical device and one or more second medical devices)
In some embodiments, the first elongated or expandable body 10 of the second medical device 1 is a wire assembly, a coiled wire assembly, a braided wire assembly, a woven wire assembly, or other expandable body 10 including. In some embodiments, first elongated or expandable body 10 of second medical device 1 is a self-expanding wire assembly, a coiled wire assembly, a braided wire assembly, a woven wire assembly, or other expandable wire assembly. It includes a body 10 . In some embodiments, the expandable body 10 of the wire assembly, coiled wire assembly, braided wire assembly, or woven wire assembly, when not in a compressed, deflated, constrained or elongated configuration, is in the first It is configured to form the general shape and size of the expanded removable balloon of medical device 1 .

In some embodiments, the second elongated body 721 of the second medical device 700 is a first elongated or expandable body pushed distally against the distal tip of the second catheter 174 by the user. body 720 length can be determined. In some embodiments, the hub 178 of the second catheter 174 of the detachable balloon catheter 1 connects the distal end of the first elongated or expandable body 720 to the second catheter 174 of the detachable balloon catheter 1 . A carrier configured for insertion into lumen 163 of catheter 174 and for containing, constraining or otherwise engaging at least a portion of first elongated or expandable body 720 and second elongated body 721 It is also configured to be joined with the distal end of the structure or carrier. This helps the physician to use long or very long coils up to 400 cm or more in length by providing a longer rigid path for guiding the coil or first elongated body 720 to the patient. In one example, the second catheter 174 of the removable balloon catheter 1 is 130 cm long and the carrier structure is 300 cm long. When the hub 178 of the second catheter 174 of the detachable balloon catheter 1 is joined to the carrier, then a first elongated or expandable body 720 of 400 cm along with a second elongated body 721 of 430 cm in length. can be used. Once the distal end of second elongated body 721 is pushed into the proximal end of second catheter 174 of detachable balloon catheter 1, the carrier and second catheter 174 of detachable balloon catheter 1 are then pushed into place. The second catheter 721 can be separated and used to detach from the carrier and push the remainder of the first elongated or expandable body 720 out of the second catheter 174 of the removable balloon catheter 1. can be done. In some embodiments, the carrier is configured in a coil shape. In some embodiments, a portion of first or expandable elongated body 720 of second medical device 1 contacts the inner surface of expanded removable balloon 10 of first medical device 1 . configured to In some embodiments, the maximum overall or tertiary diameter of first elongated or expandable body 720 of second medical device 700 is the maximum diameter of expanded removable balloon 10 of first medical device 1 . It ranges from 5% smaller than the diameter to 20% larger than the maximum diameter of the inflated removable balloon 10 of the first medical device 1 . In some embodiments, the maximum overall or tertiary diameter of first elongated or expandable body 720 of second medical device 700 is less than that of expanded removable balloon 10 of first medical device 1 . 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 mm larger than the maximum diameter. In some embodiments, the volume of the one or more first elongated or expandable bodies of the second medical device 1 is 5-75% of the volume of the central void 115 of the expanded removable balloon 10. meet.

(Kit including a first medical device and one or more second medical devices)
As disclosed herein, aspects and embodiments relate to kits incorporating first and second medical devices 1 &700. Such kits include at least one first medical device 1 and one or more second medical devices 700 configured for use with the first medical device 1 .

In one example, the kit includes one first medical device 1 configured for use with a 0.014 inch guidewire 40 having a 6 mm diameter, 10 mm long removable polymer balloon 12, and a first When elongated body 720 is configured without a tertiary shape or structure and has a secondary diameter of 0.014 inches and is positioned entirely within central void 115 of expanded detachable balloon 10 of first medical device 1 . , and a length that provides a packing density of 25%.

Such kits may further include additional medical devices. In one embodiment, the kit may include a first medical device 1 , a second medical device 700 and a guidewire 40 configured for use with the first medical device 1 , the first medical device 1 and may have a length greater than the length of the second catheter 174 of the first medical device 1 .

In some embodiments, the kit causes separation of the first medical device 1, the second medical device 700 and i) the first catheter 173 of the first medical device 1 and the removable balloon 10, ii) ) separating the first elongated or expandable body 720 from the second elongated body 721; or iii) separating the first catheter 173 and the removable balloon 10 of the first medical device 1; A detachment controller 406 may also be included that is configured to cause one elongated or detachable body 720 to be detached from a second elongated body. In some embodiments, the kit is i) between the first medical device 1 and the controller 406, ii) between the second medical device 700 and the controller 406, or iii) the first medical device 1 and the controller 406 and between the second medical device 700 and the controller 406 .

(Device usage example)
A series of steps are associated with deployment of the removable balloon within the saccular aneurysm. Initially, the guidewire may be positioned so that its distal tip is within the lumen of the aneurysm sac. A first medical device comprising a pleated, folded removable balloon is then passed over the guidewire through the neck or mouth of the aneurysm. can move forward. After the pleated and folded removable balloon is placed within the lumen of the aneurysm sac, it is examined during fluoroscopy to assess the position of the pleated and folded removable balloon. Radiation or X-ray contrast agents can be injected into the parent artery. Once proper positioning of the removable balloon within the lumen of the aneurysm sac has been achieved and confirmed, the removable balloon is then inflated or expanded. A fluid medium source such as a syringe, an inflation device (e.g., the Endoflator® by Karl Storz, not shown), or a pump is connected to the inflation port of the hub of the first catheter, and the fluid medium is removable from the balloon. is injected into the central space of the aneurysm, which causes expansion of the removable balloon until it fills at least a portion of the lumen of the aneurysm sac. After expansion, the first catheter is pulled back into the aneurysm lumen, drawing the expanded removable balloon to the neck of the aneurysm. After the inflated balloon is placed in the neck of the aneurysm, radiation or x-ray contrast is administered during fluoroscopy to assess the position of the inflated balloon and to confirm neck occlusion of the aneurysm. It may be injected into the parent artery. A second catheter is then advanced into the lumen of the aneurysm sac, the guidewire is removed, and one or more first elongated bodies or coils are passed through the lumen of the second catheter (the second lumen) into the aneurysm. It can be pumped into the lumen of the sac. A first elongated body or coil applies continuous force to the removable balloon providing a tight seal between the expandable balloon and the aneurysm neck. After placement of the elongated object or coil in the lumen of the aneurysm sac, radiation or an x-ray contrast agent is injected into the parent artery during fluoroscopy to assess the location of the first elongated body or coil and the aneurysm neck. Check for partial blockage. The second catheter is then pulled back into the central void of the removable balloon and the one or more first elongated bodies or coils are extended through the lumen of the second catheter (the second lumen). It may also be delivered into the central void of the balloon. A first elongated body or coil exerts an outward force on the inner wall of the expanded removable balloon to keep the expanded removable balloon in the expanded state; Maintaining contact between the inner wall of the aneurysm; Collapse of the removable balloon by external compressive forces, including external compressive forces from portions of the first elongated body or coil residing in the lumen of the aneurysm sac. , compression, or compaction. The central void or interior volume of the first elongated body or coil disposed within the lumen of the aneurysm sac and the removable balloon may be separate or the same. In some embodiments, the same first elongated body or coil is placed in both locations, with the distal portion of the first elongated body or coil first placed in the lumen of the aneurysm sac, followed by the second The two catheters are retracted so that the proximal portion of the first elongated body or coil can be positioned in the central void of the removable balloon. Finally, the first catheter is removed from the removable balloon (together with the second catheter) and the removable balloon and elongated body or coil are placed within the lumen of the aneurysm sac and centrally of the removable balloon. Leave in the void to occlude the neck and aneurysm sac.

A series of steps are associated with the deployment of a removable balloon within an artery, vein or biological conduit. Initially, the guidewire may be positioned so that its distal tip lies within the lumen of an artery, vein, or biological conduit. A first medical device comprising a pleated, folded detachable balloon may then be advanced over the guidewire into the segment of the artery, vein or biological conduit selected for occlusion. . After the lumen of a selected segment of an artery, vein or biological conduit is pleated and the folded removable balloon is placed, radiation or an x-ray contrast agent is applied to the artery, vein or biological conduit during fluoroscopy. The position of the detachable balloon that was pleated and folded may be evaluated. Once proper positioning of the removable balloon within the lumen of the artery, vein or biological conduit has been achieved and confirmed, the removable balloon is inflated or expanded. A source of fluid medium such as a syringe, an inflation device (e.g. Endoflator® by Karl Storz, not shown), or a pump is connected to the inflation port of the hub of the first catheter and the fluid medium is applied to the removable balloon. Injecting into the central space causes expansion of the removable balloon until it fills at least a portion of the lumen of the artery, vein or biological conduit. After the inflated balloon is placed in the lumen of the artery, vein or biological conduit, radiological or X-ray contrast agents are injected into the lumen of the artery, vein or biological conduit during fluoroscopy to determine the position of the inflated balloon. to check for occlusion of arteries, veins or biological conduits. The guidewire may be removed. Optionally, a solution containing the drug or therapeutic agent, a solution or suspension containing the embolic particles, or a combination thereof is injected into the lumen of the target segment of the artery, vein, or biological conduit. The distal end of the first elongated body or coil passes through the lumen of the second catheter (the second lumen) into the inflated removable balloon adjacent and distal to the artery, vein or biological conduit. can be sent into the lumen. The second catheter is then retracted into the central void of the expanded removable balloon and the rest of the first elongated body or coil is expanded through the lumen of the second catheter (the second lumen). can be fed into the central void of the attached removable balloon. Optionally, an additional first elongated body or coil may be fed through the lumen of a second catheter (second lumen) and into the central void of the expanded removable balloon. A first elongated body or coil exerts an outward force on the inner wall of the expanded removable balloon to keep the expanded removable balloon in an expanded state; the outer wall of the removable balloon and the artery; Maintaining contact between the inner wall of the vein or biological conduit; Releasable by external compressive force, including external compressive force from a portion of the first elongated body or coil present in the lumen of the artery, vein, or biological conduit prevent excessive balloon deflation, compression or consolidation. The central cavity or internal volume of the first elongated body or coil disposed within the lumen of the artery, vein or biological conduit and the removable balloon may be separate or the same. Finally, the first catheter (together with the second catheter) is removed from the removable balloon and the removable balloon, elongated body or coil and center of the removable balloon within the lumen of the artery, vein or biological conduit. Occlude an artery, vein or biological conduit, leaving a space.

After access to the left atrium, a sequence of steps involves deployment of a removable balloon within the left atrial appendage (LAA). First, a guidewire may be positioned so that its distal end is within the lumen of the LAA. A first medical device comprising a pleated, folded detachable balloon may then be advanced over the guidewire and through the neck or ostium of the LAA. After the pleated and folded detachable balloon is placed in the lumen of the LAA sac, a radiation or radiographic contrast agent is injected into the parent artery during fluoroscopy to form the pleats and fold. The position of the removable balloon may be assessed. Once proper positioning of the detachable balloon within the lumen of the LAA sac is achieved and confirmed, the third catheter is withdrawn to expand the retention structure and the arms and hooks of the retention structure in the wall of the LAA. resulting in engagement of Verify sufficient wall engagement by gently pulling on the first catheter. A removable balloon is inflated or expanded. A source of fluid medium such as a syringe, an inflation device (e.g. Endoflator® by Karl Storz, not shown), or a pump is connected to the inflation port on the hub of the first catheter to inject the fluid medium into the central void. , resulting in expansion of the removable balloon until it fills at least a portion of the lumen of the LAA sac. After expansion of the removable balloon, a radio- or x-ray contrast agent is injected into the left atrium during fluoroscopy to assess the position of the expanded balloon and confirm LAA occlusion. A second catheter is pulled back into the central void of the expanded removable balloon and one or more first elongated bodies or coils are expanded through the lumen of the second catheter (second lumen). It can be fed into the central void of the detachable balloon. a first elongated body or coil exerting an outward force on the inner wall of the expanded removable balloon to keep the expanded removable balloon in an expanded state; Maintains contact between the inner wall; prevents deflation, compression or compaction of the removable balloon due to external compressive forces, including external compressive forces. Finally, the first catheter is detached from the removable balloon and removed (along with the second and third catheters), and the removable balloon, retention structure and elongated body or coil are removed from the removable balloon. The neck and pouch of the LAA are occluded, leaving in the central space of the LAA.

After access to the left atrium, a sequence of steps involves deployment of a removable balloon within the LAA. First, a guidewire can be placed so that its distal end is within the lumen of the LAA sac. Next, a first medical device comprising a pleated, folded removable balloon is advanced over the guidewire into the lumen of the LAA, and the pleated, folded removable balloon is advanced into the lumen of the LAA. It may be positioned so that the proximal end is at the neck of the LAA. After forming the pleats and placing the folded removable balloon, a radiation or radiographic contrast agent is injected into the parent artery during fluoroscopy to form the pleats and position the folded removable balloon. may be evaluated. Once proper positioning of the removable balloon within the lumen of the LAA has been achieved and confirmed, the removable balloon is inflated or expanded. A source of fluid medium, such as a syringe, inflation device (e.g., Endoflator® by Karl Storz, not shown), or pump, is connected to an inflation port on the hub of the first catheter, and the fluid medium is removable. Injected into the central void of the balloon, causing expansion of the removable balloon until it occludes the neck of the LAA and fills at least a portion of the lumen of the LAA sac. After the inflated balloon is placed in the neck of the LAA, radiation or X-ray contrast is injected into the parent artery during fluoroscopy to assess the location of the inflated balloon and occlusion of the LAA neck. can be checked. A second catheter is then advanced into the lumen of the LAA sac, the guidewire is removed, and one or more first elongated bodies or coils are passed through the lumen of the second catheter (the second lumen) into the LAA sac. can be delivered into the lumen of A first elongated body or coil exerts a continuous force on the removable balloon providing a tight seal between the expanded balloon and the neck of the LAA. After placement of the elongated body or coil within the lumen of the LAA sac, radiological or radiographic contrast agents are injected into the parent artery during fluoroscopy to assess the position of the first elongated body or coil and to assess the neck of the LAA. You may also check for occlusion of the part. The second catheter is then pulled back into the central void of the removable balloon and one or more first elongated bodies or coils are passed through the lumen of the second catheter (the second lumen) to the expanded detachment. It can be fed into the central void of the balloon where possible. a first elongated body or coil exerting an outward force on the inner wall of the expanded removable balloon to keep the expanded removable balloon in an expanded state; maintaining contact between the inner wall; deflating, compressing or consolidating the removable balloon by external compressive forces, including external compressive forces from the portion of the first elongated body or coil residing within the lumen of the LAA sac; To prevent. The central void or interior volume of the first elongated body or coil disposed within the lumen of the LAA sac and the removable balloon may be separate or the same. In some embodiments, the same first elongated body or coil is placed in both locations, with the distal portion of the first elongated body or coil first placed in the lumen of the LAA sac and then the second. The catheter is pulled back so that the proximal portion of the first elongated body or coil can be positioned in the central void of the removable balloon. Finally, the first catheter (together with the second catheter) is detached and removed from the removable balloon, placing the removable balloon and elongated body or coil within the lumen of the LAA sac and the central void of the removable balloon. left in place to occlude the neck and LAA sac.

Various drawings and images related to various aspects of the use, deployment, assembly, and experimental testing of various embodiments of the devices, systems and methods disclosed herein are shown in Figures 104-129. The figures relate to Examples 1-26, which are described in more detail below.

(Example on a bench (or work table: Bench) and example of use in vivo)
Examples 1, 6 and 11 demonstrate the treatment of canine venous sac end bifurcation aneurysms with metal balloons and coils. Animal 15C035 was treated with study GNA1504W. Efficacy of treatment was assessed by angiography and histology.

A surgical procedure was performed to create a carotid bifurcation in the right neck and a segment of the external jugular vein was used to create a single venous pouch end bifurcation aneurysm. After aneurysm creation, angiography was used to assess the size, shape, patency and blood flow of the parent vessel and aneurysm. Parent vessel diameter and aneurysm size (including neck diameter, aneurysm width, height and depth) were determined using QVA on the day of aneurysm creation.

The distal carotid bifurcation aneurysm in animal 15C035 was treated with a Ballstent Microcatheter, an 8 mm x 6 mm metal balloon (gold body, stainless steel and gold proximal neck, gold distal neck). After inflation of the balloon, four barricade coils (Blockade Medical, Inc.) were placed through the lumen of the second catheter of the Ballstent Microcatheter into the dome of the aneurysm behind the inflated balloon. Barricade coils were removed electrolytically using a standard barricade removal box and handheld removal cable (Blockade Medical, Inc.). A modified barricade removal box with a 3 minute duty cycle (or duty cycle) after placement of the barricade coil and a modified barricade handheld removal cable adapted to connect to the proximal hub of the Ballstent Microcatheter. The expanded balloon was removed from the first catheter by electrolysis using . Immediately after treatment, the interventional physician estimated that the aneurysm was 95% occluded. A final angiogram of animal 15C035 was performed 28 days after treatment. Angiography was used to determine aneurysm occlusion rate (%), aneurysm size (including neck diameter and aneurysm width, height and depth), parent vessel patency and diameter and balloon or barricade coils. were assessed visually for protrusion into the parent vessel. A QVA was performed to assess parent vessel diameter and aneurysm size. On the final day, animal 15C035 underwent a limited necropsy. Right neck aneurysm tissue and adjacent vessel segments were collected including the test article. At final follow-up, the interventional physician estimated the aneurysm to be 95-100% occlusive.

Aneurysm sites and reference vessels were excised and treated with paraffin. The remaining explants were treated and embedded in Spurr resin. The resulting block was then segmented to contain 3 consecutive aneurysm levels. Two slides were made at each level of each aneurysm and reference artery segment and stained with hematoxylin and eosin (H&E) and elastin trichrome (ET). All obtained slides were examined for aneurysm occlusion, parent vessel patency, endothelialization of the implanted balloon and coil, tissue reaction and inflammatory response around the implanted balloon and coil, and healing of the aneurysm sac. evaluated. Histological analysis showed that an endothelialized neointima had progressed to complete coverage of the balloon. The neointima was generally fully mature and fibromuscular with no residual fibrin. There was complete aneurysm neck occlusion (100% occlusion).

Examples 2, 5 and 12B demonstrate the treatment of canine venous lateral wall aneurysms with metal balloons and coils. Animal 15C036 was treated with study GNA1504W. Efficacy of treatment was assessed by angiography and histology.

A surgical procedure was performed to create a carotid wide jugular lateral aneurysm in the left carotid artery using a segment of the external jugular vein. After aneurysm creation, angiography was used to assess the size, shape, patency and blood flow of the parent vessel and aneurysm. Parent vessel diameter and aneurysm size (including neck diameter and aneurysm width, height and depth) were determined using QVA on the day of aneurysm creation.

The left carotid sidewall aneurysm of animal 15C036 was treated with a Ballstent Microcatheter, a 6 mm x 4.5 mm metal balloon (gold body, stainless steel and gold proximal neck, gold distal neck). After inflating the balloon, a second catheter of the Ballstent Microcatheter was advanced into the aneurysm sac while leaving the inflated balloon and first catheter fixed in place. Four barricade coils (Blockade Medical, Inc.) were placed through the lumen of the second catheter of the Ballstent Microcatheter into the dome of the aneurysm behind the inflated balloon. Barricade coils were removed electrolytically using a standard barricade removal box and handheld removal cable (Blockade Medical, Inc.). After placement of the barricade coil, expansion is by electrolysis using a modified barricade detachment box with a duty cycle of 3 minutes and a modified barricade handheld detachment cable adapted to connect to the proximal hub of the Ballstent Microcatheter. The balloon was removed from the first catheter. Immediately after treatment, the interventional physician estimated that the aneurysm was 95% occluded.

Interim and final angiograms of animal 15C036 were performed on days 36 and 63, respectively. Angiography was used to determine aneurysm occlusion rate (%), aneurysm size (including width, height, depth and neck), parent vessel patency and diameter, and balloon or barricade coil to parent vessel. prominence was assessed visually prior to termination. A QVA was performed to assess parent vessel diameter and aneurysm size. On the day of termination, animal 15C036 underwent a limited necropsy. Left carotid aneurysm tissue and adjacent vessel segments were collected including the test article. At final follow-up, the interventional physician estimated the aneurysm to be 100% occluded.

Aneurysm sites and reference vessels were excised and treated with paraffin. The remaining explants were treated and embedded in Spurr resin. The resulting block was segmented to contain 3 consecutive aneurysm levels. Two slides were made at each level of each aneurysm and reference artery segment and stained with H&E and ET. All obtained slides were examined for aneurysm occlusion, parent vessel patency, endothelialization of the implanted balloon and coil, tissue reaction and inflammatory response around the implanted balloon and coil, and healing of the aneurysm sac. evaluated. Histological analysis showed complete coverage of the balloon with endothelialized neointima. The neointima was fully mature and fibromuscular with no remaining fibrin. There was complete aneurysm neck occlusion (100% occlusion).

Example 3 demonstrates the treatment of canine venous sac compound bifurcation aneurysms with metal balloons and coils. Animal 15C026 was treated with study GNA1502W. The effect of treatment was assessed by angiography.

A surgical procedure was performed to create a carotid bifurcation in the right neck, followed by a segment of the external jugular vein used to create a complex bifurcation aneurysm. After aneurysm creation, angiography was used to assess the size, shape, patency, and blood flow of the parent vessel and aneurysm. Parent vessel diameter and aneurysm size (including neck diameter and aneurysm width, height and depth) were determined using quantitative vascular analysis (QVA) on the day of aneurysm creation. .

A compound bifurcated carotid bifurcation aneurysm in animal 15C026 was treated with an 8 mm×6 mm metal balloon Ballstent Microcatheter (gold body, stainless steel and gold proximal neck, gold distal neck). After inflation of the balloon, a second catheter of the Ballstent Microcatheter was advanced into the aneurysm sac while leaving the inflated balloon and first catheter fixed in place. A 0.014 inch guidewire was removed from the second catheter and 17 barricade coils (Blockade Medical, Inc.) were placed through the lumen of the second catheter in the dome of the aneurysm behind the inflated balloon. Barricade coils were removed electrolytically using a standard barricade removal box and handheld removal cable (Blockade Medical, Inc.). After placement of the barricade coil, expansion is by electrolysis using a modified barricade detachment box with a duty cycle of 3 minutes and a modified barricade handheld detachment cable adapted to connect to the proximal hub of the Ballstent Microcatheter. The balloon was removed from the first catheter. Immediately after treatment, the interventional physician estimated that the aneurysm was 75% occluded.

A final angiogram of animal 15C026 was performed on day 35. Angiography was used to determine aneurysm occlusion rate (%), aneurysm size (including width, height, depth and neck), parent vessel patency and diameter, and balloon or barricade parent before termination. Protrusion into vessels was assessed visually. A QVA was performed to assess parent vessel diameter and aneurysm size. On the day of termination, animal 15C026 underwent a limited necropsy. Right neck aneurysm tissue and adjacent vessel segments were collected, including the test article. At final follow-up, the interventional physician estimated the aneurysm to be 100% occluded.

Example 4 demonstrates the treatment of canine venous complex bifurcation aneurysms with metal balloons and coils. Animal 15C027 was treated with study GNA1502W. The effect of treatment was assessed by angiography.

A surgical procedure was performed to create a carotid bifurcation in the right neck followed by a segment of the external jugular vein to create a complex bifurcation aneurysm. After aneurysm creation, angiography was used to assess the size, shape, patency, and blood flow of the parent vessel and aneurysm. Parent vessel diameter and aneurysm size (including neck diameter and aneurysm width, height and depth) were determined using QVA on the day of aneurysm creation.

A complex bifurcated carotid bifurcation aneurysm in animal 15C027 was treated with a Ballstent Microcatheter, an 8 mm x 6 mm metal balloon (gold body, stainless steel and gold proximal neck, gold distal neck). After inflation of the balloon, the tip of a second catheter was advanced into the aneurysm sac, while keeping the position of the inflated balloon and the first catheter fixed, ten barricade coils (Blockade Medical) were placed in the Ballstent. It was placed in the dome of the aneurysm behind the inflated balloon through the lumen of the Microcatheter's second catheter. Barricade coils were removed electrolytically using a standard barricade removal box and handheld removal cable (Blockade Medical, Inc.). After placement of the barricade coil, expansion is by electrolysis using a modified barricade detachment box with a duty cycle of 3 minutes and a modified barricade handheld detachment cable adapted to connect to the proximal hub of the Ballstent Microcatheter. The balloon was removed from the first catheter.

Interim and final angiography of animal 15C027 was performed on day 35. Angiography was used to determine pre-termination aneurysm occlusion rate (%), aneurysm size (including width, height, depth and neck), parent vessel patency and diameter, and balloon, Metactive Accessory The protrusion of the coil or barricade coil into the parent vessel was assessed. A QVA was performed to assess parent vessel diameter and aneurysm size. On the day of termination, animal 15C027 underwent a limited necropsy. Right neck aneurysm tissue and adjacent vessel segments were collected, including the test article. At final follow-up, the interventional physician estimated the aneurysm to be 100% occluded.

Example 7 demonstrates the treatment of canine vesicular lateral aneurysms with polymeric balloons and coils. Animal 17C013 was treated with study GNA1802N. The effect of treatment was assessed by angiography.

A surgical procedure was performed to create a carotid wide jugular lateral aneurysm in the left carotid artery using a segment of the external jugular vein. After aneurysm creation, angiography was used to assess the size, shape, patency and blood flow of the parent vessel and aneurysm. Parent vessel diameter and aneurysm size (including neck diameter and aneurysm width, height and depth) were determined using QVA on the day of aneurysm creation.

A 17C013 left carotid sidewall aneurysm was treated with a Ballstent Microcatheter, a 6 mm x 4.5 mm polymer balloon. After inflation of the balloon, the tip of a second catheter was advanced into the aneurysm sac. The distal portion of one blockade barricade coil (50 cm long straight coil pre-formed with one loop of 4 mm at the distal end) was passed through the lumen of the second catheter of the Ballstent Microcatheter and into the expanded balloon. was placed in the aneurysm sac behind the The tip of the second catheter was then pulled back into the central void of the inflated balloon and the rest of the coil was placed in the central void of the inflated balloon.

Example 8 demonstrates the treatment of canine vesicular terminal bifurcation aneurysms with metal balloons and coils. The remaining patent aneurysm neck after initial treatment was treated with additional coils. Animal 15C033 was treated with study GNA1504W. The effect of treatment was assessed by angiography.

A surgical procedure was performed to create a carotid bifurcation in the right neck and then a segment of the external jugular vein was used to create a single venous sac end bifurcation aneurysm. After aneurysm creation, angiography was used to assess the size, shape, patency and blood flow of the parent vessel and aneurysm. Parent vessel diameter and aneurysm size (including neck diameter and aneurysm width, height and depth) were determined using QVA on the day of aneurysm creation.

The distal carotid bifurcation aneurysm in animal 15C033 was treated with a Ballstent Microcatheter, an 8 mm x 6 mm metal balloon (gold body, stainless steel and gold proximal neck, gold distal neck). After inflation of the balloon, one Metactive Medical Nitinol coil and three barricade coils (Blockade Medical) were placed through the lumen of the second catheter of the Ballstent Microcatheter into the dome of the aneurysm behind the inflated balloon. . A Metactive Nitinol coil was pushed out of an Accessory Coil Delivery Catheter that was advanced into the aneurysm sac using a pusher wire. Barricade coils were removed electrolytically using a standard barricade removal box and handheld removal cable (Blockade Medical, Inc.). After placement of the Metactive and Barricade Coils, electrification using a modified Barricade Detachment Box with a duty cycle of 3 minutes and a Modified Barricade Handheld Detachment Cable adapted to connect to the Ballstent Microcatheter's proximal hub. Disassembly removed the inflated balloon from the first catheter. After removing the inflated balloon, the first and second catheter assemblies were removed from the animal, the second catheter was removed from the first catheter, reinserted into the animal, and a 0.014 inch guidewire was inserted. The top was advanced to the neck segment of the aneurysm adjacent to the inflated balloon. A fourth barricade coil was placed over the residual aneurysm neck and removed as described above. Immediately after treatment, the interventional physician estimated that the aneurysm was 95% occluded.

Terminal angiography of animal 15C033 was performed on day 29. Angiography was used to determine the aneurysm occlusion rate (%), aneurysm size (including neck diameter and aneurysm width, height and depth), parent vessel patency and diameter, and access to the parent vessel. The protrusion of the balloon or barricade coil was assessed visually. A QVA was performed to assess parent vessel diameter and aneurysm size. On the final day, animal 15C033 underwent a limited necropsy. Right neck aneurysm tissue and adjacent vessel segments were collected, including the test article. At final follow-up, the interventional physician estimated the aneurysm to be 95-100% occlusive.

Example 9 demonstrates the treatment of a canine vesicular terminal bifurcation aneurysm using only a metal balloon. Animal 15C005 was treated with study GNA1502W. The effect of treatment was assessed by angiography.

A surgical procedure was performed to create a carotid bifurcation in the right neck, after which a segment of the external jugular vein was used to create a single venous sac end bifurcation aneurysm. After aneurysm creation, angiography was used to assess the size, shape, patency and blood flow of the parent vessel and aneurysm. Parent vessel diameter and aneurysm size (including neck diameter and aneurysm width, height and depth) were determined using QVA on the day of aneurysm creation.

The distal carotid bifurcation aneurysm in animal 15C005 was treated with a Ballstent Microcatheter, an 8 mm x 6 mm metal balloon (gold body, stainless steel and gold proximal neck, gold distal neck). The inflated balloon used a modified barricade detachment box (Blockade Medical, Inc.) with a duty cycle of 3 minutes and a modified barricade handheld isolation cable adapted to connect to the proximal hub of the Ballstent Microcatheter. It was removed from the first catheter by electrolysis. The coil was not placed in the aneurysm sac or inflated balloon. Immediately after treatment, the interventional physician estimated that the aneurysm was 90% occluded.

A terminal angiogram of animal 15C005 was performed on day 27. Angiography was used to determine the aneurysm occlusion rate (%), aneurysm size (including neck diameter and aneurysm width, height and depth), parent vessel patency and diameter, and access to the parent vessel. Balloon protrusion was assessed visually. A QVA was performed to assess parent vessel diameter and aneurysm size. On the final day, animal 15C005 underwent a limited necropsy. Right neck aneurysm tissue and adjacent vessel segments were collected, including the test article. At final follow-up, the interventional physician estimated the aneurysm to be 95% occluded.

Examples 10 and 11 demonstrate the treatment of canine vesicular terminal bifurcation aneurysms with coils alone. Animal 13C009 was treated with study GNA1307W. Efficacy of treatment was assessed by angiography and histology.

For animal 13C009, a surgical procedure was performed to create a carotid bifurcation in the right neck, after which a segment of the external jugular vein was used to create a single venous terminal bifurcation aneurysm. After aneurysm creation, angiography was used to assess the size, shape, patency, and blood flow of the parent vessel and aneurysm. Parent vessel diameter and aneurysm size (including neck diameter and aneurysm width, height and depth) were determined using QVA on the day of aneurysm creation.

Animal 13C009 had a distal carotid bifurcation aneurysm treated with 17 Axium coils (Medtronic) and a 2.4F Rebar-18 microcatheter (ev3) and Instant Detacher (ev3). was used to deliver it to the aneurysm sac. The calculated volume of the delivered coil was 225 ^mm3 compared to an estimated aneurysm volume of 351 ^mm3 , resulting in coil packing of 64% of the estimated aneurysm volume. The interventional physician noted minimal blood flow to the aneurysm neck coil complex after treatment, but was unable to deliver additional coils. Immediately after treatment, the interventional physician estimated that the aneurysm was 85-99% closed.

A final angiogram was performed on animal 13C009 on day 25. Angiography was used to determine the aneurysm occlusion rate, aneurysm size (including neck diameter and aneurysm width, height and depth), parent vessel patency and diameter, and balloon projection into the parent vessel. Sections were assessed visually. A QVA was performed to assess parent vessel diameter and aneurysm size. On the final day, animal 15C005 underwent a limited necropsy. Right neck aneurysm tissue and adjacent vessel segments containing the Axium coil were collected. At final follow-up, the interventional physician estimated the aneurysm to be 85-99% occlusive.

Aneurysm sites and reference vessels were excised and treated with paraffin. The remaining explants were treated and embedded in Spurr resin. The resulting block was segmented to contain 3 consecutive aneurysm levels. Two slides were made at each level for each aneurysm and reference artery segment and stained with H&E and ET. All obtained slides were examined for aneurysm occlusion, parent vessel patency, endothelialization of the implanted balloon and coil, tissue reaction and inflammatory response around the implanted balloon and coil, and healing of the aneurysm sac. evaluated. Histological analysis showed incomplete coverage of the coil by endothelialized neointima due to marked recanalization of the neck. The rate of neck occlusion was low (50% at 2 out of 3 section levels) because there was a dense network of broad recanalization channels to the aneurysm body, extending centrally within the sac. There was marked neovascularization in the sac between the coils. The upper half of the aneurysm showed a dense network of wide vascular channels.

See Example 1 for treatment of animal 15C035.

Example 12A demonstrates the treatment of canine vesicular terminal bifurcation aneurysms with metal balloons and coils. Animal 15C008 was treated with study GNA1502W. The effect of treatment was assessed by histological examination.

A surgical procedure was performed to create a carotid bifurcation in the right neck, after which a segment of the external jugular vein was used to create a single venous pouch end bifurcation aneurysm. After aneurysm creation, angiography was used to assess the size, shape, patency, and blood flow of the parent vessel and aneurysm. Parent vessel diameter and aneurysm size (including neck diameter and aneurysm width, height and depth) were determined using QVA on the day of aneurysm creation.

The distal carotid bifurcation aneurysm in animal 15C008 was treated with a Ballstent Microcatheter, an 8 mm x 6 mm metal balloon (gold body, stainless steel and gold proximal neck and gold distal neck). After inflation of the balloon, 12 barricade coils (Blockade Medical, Inc.) were placed through the lumen of the second catheter of the Ballstent Microcatheter into the dome of the aneurysm behind the inflated balloon.
Barricade coils were removed electrolytically using a standard barricade removal box and handheld removal cable (Blockade Medical, Inc.). After placement of the barricade coil, it was expanded by electrolysis using a modified barricade detachment box with a duty cycle of 3 minutes and a modified barricade handheld detachment cable adapted to connect with the proximal hub of the Ballstent Microcatheter. The balloon was removed from the first catheter.

Terminal angiography of animal 15C035 was performed on day 85. On the final day, animal 15C008 underwent a limited necropsy. Right neck aneurysm tissue and adjacent vessel segments were collected, including the test article. Aneurysm sites and reference vessels were excised and treated with paraffin. The remaining explants were treated and embedded in Spurr resin. The resulting block was segmented to contain 3 consecutive aneurysm levels. Two slides were made at each level for each aneurysm and reference artery segment and stained with H&E and ET. All obtained slides were examined for aneurysm occlusion, parent vessel patency, endothelialization of the implanted balloon and coil, tissue reaction and inflammatory response around the implanted balloon and coil, and healing of the aneurysm sac. evaluated. Histological analysis showed complete coverage of the balloon with endothelialized neointima. The neointima was fully mature and fibromuscular with no remaining fibrin. There was complete aneurysm neck occlusion (100% occlusion).

Examples 13 and 14 demonstrate treatment of a segment of the canine internal mammary artery with a metal balloon, an Amplatzer vascular plug IV, or a Cook Nester coil. Animals 15C001, 15C004, 17C006 and 17C008 were treated with studies GNA1501W and GNA1701W. The effect of treatment was assessed by angiography.

On the day of treatment (Day 0), all animals received an interventional procedure in which bilateral occlusion of the internal mammary arteries was attempted with test and control articles. Animals were prepared for surgery per protocol. Contrast angiography was performed on Day 0 before treatment, during treatment (when possible), and after treatment. A QVA was performed prior to placement of the test and control articles to ensure that target vessel segments were selected such that the diameter of the test and control articles was 25-50% larger than the diameter of the target vessel.

A single 4 mm metal balloon Blockstent Microcatheter (gold body and neck), a single 4 mm Amplatzer vascular plug IV, or two 3 mm Cook Nester coils were implanted in the dog's internal mammary artery. If necessary, the treated vessel segment was monitored by serial angiography until complete occlusion of the target vessel segment was observed or 60 minutes had elapsed. In study GNA1501W, 100% immediate occlusion was observed in 2 of 4 Blockstent (4 mm) treatments and 0 of 4 Cook Nester coil treatments. In study GNA1701W, 100% immediate occlusion was observed with 4 of 4 Blockstent (4 mm) treatments and 4 of 4 Amplatzer Vascular Plug IV treatments. The average balloon inflation pressure was 3 atmospheres. Mean time to complete occlusion was greater than 30 minutes with the Amplatzer Vascular Plug IV treatment.

At the final follow-up time of 27 days, all animals were evaluated using contrast angiography to determine the degree of occlusion of test article and/or control article treated vessels. On the final day, animals underwent a limited necropsy. The treated tissue and adjacent vessel segments were collected, including the test article. In study GNA1501W, 100% chronic occlusion was observed in 4 of 4 Blockstent (4 mm) treatments and 0 of 4 Cooknester coil treatments. In study GNA1701W, 100% chronic occlusion was observed in 3 of 4 Blockstent (4mm) treatments and 0 of 4 Amplatzer Vascular Plug IV treatments.

Example 15 demonstrates treatment of a bleeding canine carotid artery with a metal balloon. Animal 17C002 was treated with study GNA1701W. The effect of treatment was assessed by angiography.

The right carotid artery was exposed and an arteriotomy was performed with a 4 Fr introducer sheath to induce controlled bleeding, followed by treatment with a 6 mm metal balloon Blockstent Microcatheter (gold body and neck). Time to complete hemostasis was assessed using serial angiography to detect extravasation and direct visualization to detect vascular bleeding. Bleeding stopped completely immediately after balloon placement.

Example 16 demonstrates treatment of a bleeding canine carotid artery with the Amplatzer Vascular Plug II. Animal 17C001 was treated with study GNA1701W. The effect of treatment was assessed by angiography.

The right carotid artery was exposed and an arteriotomy was made with a 4 Fr introducer sheath to induce controlled bleeding and then treated with a 6 mm Amplatzer vessel plug II. Time to complete hemostasis was assessed using serial angiography to detect extravasation and direct visualization to detect vascular bleeding. There was persistent bleeding after treatment with Amplatzer Vascular Plug II.

Example 17 demonstrates advancement of a metal balloon over a guidewire into the superior mesenteric artery of a dog. Animal 17C005 was treated with study GNA1701W. Whole body was assessed by angiography.

A 0.014 inch guidewire was placed in the superior mesenteric artery, pleated, and a folded 4 mm metal balloon Blockstent Microcatheter (gold body and neck) was placed over the guidewire into the superior mesenteric artery. It was advanced without difficulty into the artery.

Example 18 demonstrates treatment of a dog's axillary artery with a metal balloon. Animal 17C003 was treated with study GNA1701W. The effect of treatment was assessed by angiography.

On the day of treatment (Day 0), animal 17C003 received an interventional procedure that attempted bilateral occlusion of the axillary arteries with test and control articles. Contrast angiography was performed on Day 0 before treatment, during treatment (when possible), and after treatment. A QVA was performed prior to placement of the test and control articles to ensure that the target vessel segment was selected such that the diameter of the test and control articles was 25-50% larger than the diameter of the target vessel.

A single 6 mm metal balloon Blockstent Microcatheter (gold body and neck) or a single Amplatzer vascular plug II was implanted in the dog's axillary artery. If necessary, the treated vessel segment was monitored with serial angiography until complete occlusion of the target vessel segment was observed or 60 minutes had elapsed. In study GNA1701W, 100% immediate occlusion was observed with 4 of 4 Blockstent (6 mm) treatments and 4 of Amplatzer Vascular Plug II treatments. Average balloon inflation pressures were less than 4 atmospheres. The mean time to complete occlusion was over 30 minutes with the Amplatzer Vascular Plug II treatment.

At the final follow-up time of 28 days, animals were evaluated using contrast angiography to determine the extent of occlusion of treated vessels. On the final day, animals underwent a limited necropsy. Treated tissue and adjacent vessel segments were collected, including test and control articles. In study GNA1701W, 100% chronic occlusion was observed in 4 out of 4 Blockstent (6 mm) treatments and 0 out of 4 Amplatzer Vascular Plug II treatments.

Example 19 demonstrates placement of a coil within an expanded metal balloon within the canine carotid artery. Animal 17C008 was treated with study GNA1701W. The effect of treatment was assessed by angiography.

A single 6 mm metal balloon Blockstent Microcatheter (gold body and neck) was implanted in the dog's right carotid artery. Treated vessel segments were monitored with serial angiography. After complete occlusion of the carotid artery is confirmed, the guidewire is removed, the second catheter of the Blockstent Microcatheter is pulled back until its tip is inside the inflated balloon, and the second catheter is pulled back into the balloon. It was removed from the elastomeric valve present in the distal nosecone that was attached to the distal neck of the. A 6 mm coil was placed in the inflated balloon through the lumen of the second catheter. Coils were detached electrolytically using a standard barricade detachment box and handheld detachment cable (Blockade Medical, Inc.).

Example 20 demonstrates treatment of the canine internal mammary artery with a metal balloon. Animal 17C006 was treated with study GNA1701W. The effect of treatment was assessed by angiography.

On the day of treatment (day 0), animals received an interventional procedure to occlude the internal mammary arteries bilaterally. Animals were prepared for surgery per protocol. Contrast angiography was performed on day 0 before treatment, during treatment (when possible), and after treatment. A QVA was performed prior to placement of the test and control articles to ensure that the target vessel segment was selected such that the diameter of the test and control articles was 25-50% larger than the diameter of the target vessel.

A single 4 mm metal balloon Blockstent Microcatheter (gold body and neck) or a single 4 mm Amplatzer vascular plug IV was implanted in the dog's internal mammary artery. Treated vessel segments were monitored with serial angiography as needed. See Examples 13 and 14 for the acute results of this study.

At the final follow-up time of 28 days, animals were evaluated using contrast-enhanced angiography to determine the extent of occlusion of treated vessels. On the final day, animals underwent a limited necropsy. Treated tissue and adjacent vessel segments were collected, including test and control articles. See Examples 13 and 14 for the chronic results of this study.

Example 21 demonstrates treatment of a segment of the canine internal mammary artery with a metal balloon, Amplatzer vascular plug IV, or Cook Nester coil. Animals 15C004, 17C005 and 17C006 were treated with studies GNA1501W and GNA1701W. The efficacy of treatment was assessed by histopathology.

On the day of treatment (day 0), all animals underwent an interventional procedure in which bilateral occlusion of the internal mammary artery was attempted with test and control articles. Animals were prepared for surgery per protocol. Contrast angiography was performed on Day 0 before treatment, during treatment (when possible) and after treatment. A QVA was performed prior to placement of the test and control articles to ensure that target vessel segments were selected such that the diameter of the test and control articles was 25-50% larger than the diameter of the target vessel.

A single 4 mm Blockstent Microcatheter (gold body and neck), a single 4 mm Amplatzer vascular plug IV, or two 3 mm Cook Nester coils were implanted in the dog's internal mammary artery. See Examples 13 and 14 for the acute angiographic results of this study.

At the final follow-up time point of 27-28 days, all animals were evaluated using contrast-enhanced angiography to determine the degree of occlusion of test and control article-treated vessels. On the final day, animals underwent a limited necropsy. Treated tissue and adjacent vessel segments were collected, including test and control articles. See Examples 13 and 14 for the chronic angiographic results of this study.

All vessels were excised, processed and embedded. The device area was embedded in epoxy resin (Spurr) and the reference level was embedded in paraffin. The resulting blocks were sectioned and stained with H&E and ET for recognition of local tissue reactions, evidence of infection, and/or immunological responses elicited by experimental procedures or devices. Three implant levels (proximal, intermediate and distal) and two reference levels (proximal reference and distal reference) were collected from each vessel. Histology showed 98% (n=4) vessel occlusion with the metal Blockstent balloon, 55% (n=4) with the Amplatzer vascular plug IV, and 81% (n=4) with the Cook Nester coil.

Examples 22, 23 and 24 demonstrate treatment of the canine axillary artery with metalized (or metalized) polymer balloons. Animal 17C014 was treated with study GNA1703N. The effect of treatment was assessed by angiography.

On the day of treatment (Day 0), all animals underwent an interventional procedure in which test article was used to attempt bilateral occlusion of the internal mammary arteries. Animals were prepared for surgery per protocol. Contrast angiography was performed on Day 0 before treatment, during treatment (when possible), and after treatment. A QVA was performed prior to test article placement to ensure that the target vessel segment was selected such that the diameter of the test article was 25-50% larger than the diameter of the target vessel.

For animal 17C014, a single 4 mm polymer and metal Blockstent Microcatheter (gold wire applied to the outer surface of the middle region of the PET balloon) was implanted in the internal mammary artery. After inflation of the balloon, a third Blockstent Microcatheter catheter is advanced forward until its distal tip abuts the proximal end of an elastomeric tubular segment bonded to the proximal neck of the balloon, while Two catheters remain fixed, the expanded balloon and Blockstent Microcatheter's first and third catheters remain fixed in place, and the second catheter is spliced to the distal neck of the balloon. separated from the elastomeric valve at the distal nosecone. A 0.014 inch guidewire was removed from the second catheter and two 6 mm barricade coils (Blockade Medical, Inc.) were advanced through the lumen of the second catheter and positioned in the central void of the balloon. Barricade coils were removed electrolytically using a standard barricade removal box and handheld removal cable (Blockade Medical, Inc.). The assembly of the first and second catheters was withdrawn while the third catheter remained fixed in place so that the expanded coiled balloon was removed from the first catheter. Immediately after removal for animal 17C014, the treated vessel segment was 100% occluded.

At the final follow-up time of 30 days, animals were evaluated using contrast-enhanced angiography to determine the extent of occlusion of treated vessels. On the final day, animal 17C014 underwent a limited necropsy. The treated tissue and adjacent vessel segments were collected, including the test article. There was 100% chronic occlusion of the treated vessel segment in animal 17C014.

Example 25 demonstrates treatment of the canine brachial artery with a polymer balloon. Animal 17C013 was treated with study GNA1802N. The effect of treatment was assessed by angiography.

On the day of treatment (Day 0), animal 17C013 underwent an interventional procedure to occlude the brachial arteries bilaterally. Animals were prepared for surgery per protocol. Contrast angiography was performed on Day 0 before treatment, during treatment (when possible), and after treatment. A QVA was performed prior to test article placement to ensure that the target vessel segment was selected such that the diameter of the test article was 25-50% larger than the diameter of the target vessel.

For animal 17C013, a single 6 mm polymeric Blockstent Microcatheter (metal-free PET balloon) was implanted in the left brachial artery. The pleated, folded balloon was placed over a 0.014 inch guidewire in the axillary artery and inflated to a pressure of less than 2 atmospheres. Blockstent did not have a distal nosecone or an elastomeric valve. A Barricade Coil (Blockade Medical, Inc.) with two 4 mm loops at the distal end was advanced through the lumen of the second catheter. A distal 4 mm loop was placed in the artery distal to the inflated balloon. With the inflated balloon and first catheter fixed in place, the tip of the second catheter was pulled back into the central void of the inflated balloon. The proximal 4 mm loop of the coil and the remainder of the coil (straight portion) were placed inside the central void of the balloon. There was 100% occlusion of the treated vessel segment immediately after coil insertion.

Example 26 demonstrates the use of mechanical latches to attach the polymeric balloon to the first catheter and the use of mechanical latches to detach the polymeric balloon from the first catheter.

Benchtop testing was performed using a detachable balloon catheter incorporating a mechanical latch attachment system. Beginning with both the guidewire and the second catheter extended beyond the distal nosecone, saline is injected into the proximal hub, as shown in Frame A, and the pressure between the first and second catheters is increased. The balloon was inflated through the annular lumen. In this configuration, the balloon resisted detachment from the first catheter under tensile load, as shown in Frame B. The second catheter is then pulled back over the proximal neck of the balloon, as shown in Frame C, to force the male tubular structure of the first catheter into the proximal neck of the balloon. unlatching from a female tubular structure mounted on the . The first catheter was then pulled back and removed from the balloon, as shown in Frame D. Finally, as shown in Frame E, the guidewire was retracted from the detached balloon.

It will be appreciated that the devices and methods of the present disclosure can be incorporated into many embodiments, only a few of which have been illustrated and described above. The disclosure herein may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered exemplary only, not limiting, and the scope of the disclosure is, therefore, indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

(Example of treatment of human patient)
Example 27 Treatment of Basilar Aneurysm Using Removable Flexible Metal-Coated Polymer Balloon Catheter and Single Elongated Body
A removable balloon catheter (or A first medical device) is provided.

The removable balloon has a proximal neck and a distal neck. The female tubular structure is bonded to the proximal neck of a removable flexible metallized polymer balloon. A distal portion of the female tubular structure protrudes into the central void of the balloon. A telescoping catheter segment with proximal and distal marker bands is joined to the distal neck of the removable balloon. A proximal portion of the retractable catheter segment protrudes into the central void of the removable balloon. Excluding the proximal and distal neck lengths, the removable balloon has a diameter of 8 mm (measured in a plane parallel to the second axis) and a length of 5.3 mm (parallel to the first axis). measured on a smooth plane). The proximal region 110 and distal region 120 of the removable balloon are rounded. The wall of the removable balloon comprises an inner layer of PET with a single wall thickness of 10 μm made by blow molding and an outer layer of gold with a single wall thickness of 1000 Å made by sputter deposition on the outer surface of the PET base layer.

The first catheter includes a proximal end having a hub containing a port for infusion of fluid and a distal end generally opposite the proximal end; The distal end of the catheter is joined to the proximal end of a male tubular structure having three arms and tabs. The distal end of the male tubular structure is operably connected to a female tubular structure that is joined to the proximal neck of the removable balloon. The distal end of the first catheter further includes a fluoroscopic marker band. The first catheter hub also includes a rotating, valved lock configured to secure the first catheter hub to the second catheter shaft. A second catheter includes a proximal end having a hub containing a port for receiving a 0.014 inch guidewire and an open distal end. The second catheter further includes two fluoroscopic marker bands to facilitate placement and removal of the first elongated body. The second catheter is longer than the first catheter. The proximal portion of the second catheter passes through the hub of the first catheter and is secured to the hub of the first catheter by a rotating valve block. A central portion of the second catheter passes through the lumen of the first catheter. The distal portion of the second catheter is pleated and passed through the proximal neck opening, the central void, the distal neck opening, and the telescoping catheter segment of the folded detachable balloon, and detachable. It extends distally to the distal end of the telescoping catheter segment of the possible balloon. The inner surface of the first catheter and the outer surface of the second catheter allow passage of the fluid medium from the proximal end of the first catheter to the distal end of the first catheter and into the central void of the removable balloon. An enabling first lumen is defined. A lumen of the second catheter defines a second lumen.

A physician advances a needle into the right femoral artery of a patient with a terminal saccular aneurysm of the basilar artery and advances a 0.035 inch guidewire retrograde into the artery. The needle is removed and a 6Fr introducer sheath is placed in the right femoral artery. A 6 Fr guide catheter with a Tuohy-Borst adapter is inserted through the introducer sheath and advanced over the guidewire to the origin of the right vertebral artery. A standard digital subtraction angiogram is performed to confirm the size of the aneurysm. The aneurysm neck diameter measures 6 mm, the aneurysm width and depth 9 mm, and the aneurysm height 12 mm. The 0.035 inch guidewire is removed and a 300 cm 0.014 inch guidewire is inserted and advanced until its tip enters the aneurysm sac. The physician removes residual air from the removable balloon catheter, forms pleats, and advances the folded removable balloon over the guidewire until it is centered in the aneurysm sac. An inflation device filled with a mixture of 50% saline and 50% X-ray contrast (by volume) was attached to the inflation port of the first catheter, and the inflation device was used to expand the saline and contrast. The mixture is injected through the first catheter lumen into the central void of the balloon at a pressure of 2 atmospheres, resulting in full inflation of the balloon. The physician then removes the expanded removable balloon by pulling on the assembly of the first and second catheters until the proximal surface of the expanded removable balloon contacts the neck of the aneurysm. pull back. Injection of radiographic contrast through a 6 Fr guide catheter using a Tuohy-Borst sidearm confirms neck occlusion of the aneurysm by the inflated removable balloon. The physician opens the valved rotation lock in the hub of the first catheter to allow movement of the second catheter and places the tip of the second catheter over the guidewire into the unfilled artery with the inflated removable balloon. Advance to the distal end of the aneurysm sac while maintaining the position of the inflated removable balloon and first catheter. The 0.014 inch guidewire is removed. Detachment of the aneurysm by the dilated removable balloon by injection of an X-ray contrast agent through the lumen of the second catheter, into the hub of the second catheter, and into the lumen of the vein distal to the dilated removable balloon. Occlusion is confirmed. The physician then selects a second medical device comprising a 100 cm long first elongated body comprising a coiled platinum wire joined to a second elongated body comprising a pusher wire. The first elongate body has a secondary diameter of 0.014 inches and includes a single 4 mm tertiary loop at the distal end, the remainder of the first elongate body having no tertiary shape when relevant. . The first elongated body is joined to the second elongated body (pusher wire) by mechanical attachment. The guidewire is removed from the lumen of the second catheter and the first elongated body is inserted into the lumen of the second catheter and advanced under fluoroscopy into the aneurysm sac. The physician advances the distal 70 cm of the first expandable body into the aneurysm sac using visual markings on the second elongated body of the second medical device for guidance. . While advancing the first expandable body into the aneurysm sac, the physician increases pressure within the inflation device and removable balloon to maintain complete balloon expansion. Injection of radiocontrast through a 6 Fr guide catheter using the side arm of the Tuohy-Borst adapter resulted in occlusion of the aneurysm neck with the dilated removable balloon and dilated removable balloon plus the thorax. Proper placement of the elongate body of 1 is confirmed. Under fluoroscopy, a second catheter has its tip within the central cavity of the dilated removable balloon and a telescoping catheter segment coupled to the distal neck of the dilated removable balloon. The proximal portion is withdrawn proximally while the removable balloon and first catheter remain fixed and unchanged. The physician then advances the remaining 30 cm of the first expandable body into the central void of the expanded removable balloon. Injection of radiocontrast through a 6 Fr guide catheter using the side arm of the Tuohy-Borst adapter resulted in occlusion of the aneurysm neck with the dilated removable balloon and dilated removable balloon with the dilated balloon. Proper placement of the elongate body of 1 is confirmed. The physician places the proximal end of the second elongated body of the second medical device into a handle provided on the second medical device to remove the first elongated body from the second elongated body and remove the first elongated body from the patient. Remove 2 elongated bodies. The physician then withdraws the tip of the second catheter until it is in close proximity to the bond between the male and female tubular structures, breaking the bond between the male and female structures. The physician then uses a marker band on each catheter and a radiopaque female tubular structure bonded to the proximal neck of the removable balloon to confirm separation, and then dilated and removed. The first and second catheters are withdrawn from the patient, leaving the balloon and first elongated body within the aneurysm sac. Proper placement of the expanded removable balloon and the first elongated body with the expanded removable balloon by injection of a radiocontrast agent through a 6 Fr guide catheter using the side arm of the Tuohy-Borst adapter. confirms complete occlusion of the aneurysm neck and sac. The physician then removes the right femoral artery introducer sheath and seals the hole in the right femoral artery with a closure device, successfully occluding the saccular aneurysm. Over the next few months, the elongated body within the central void of the balloon helps the balloon resist deflation, compression or compaction. A thin outer layer of gold on the surface of the balloon induces a complete layer of new endothelium on the blood-contacting surface of the balloon that completely seals the neck of the aneurysm and also a capsule of tissue that holds the balloon in place. induce formation.

Example 28 Treatment of Basilar Aneurysm Using Removable Rigid Metal-Coated Polymer Balloon Catheter and Single Elongated Body
A detachable balloon catheter (or first medical device) comprising a pleated and folded detachable rigid metallized polymeric balloon and a catheter assembly including a first catheter and a second catheter. device) is provided.

The removable balloon has a proximal neck and a distal neck. The female tubular structure is bonded to the proximal neck of a removable flexible metallized polymer balloon. A distal portion of the female tubular structure protrudes into the central void of the balloon. A telescoping catheter segment with proximal and distal marker bands is joined to the distal neck of the removable balloon. A proximal portion of the retractable catheter segment protrudes into the central void of the removable balloon. Excluding the proximal and distal neck lengths, the removable balloon has a diameter of 8 mm (measured in a plane parallel to the second axis) and a length of 5.3 mm (measured in a plane parallel to the first axis). ). The proximal region 110 and distal region 120 of the removable balloon are curvilinear. The walls of the removable balloon consisted of an inner layer of 10 μm single wall thick PET made by blow molding, an intermediate layer of 1000 Å single wall thick gold made by sputter deposition on the outer surface of the PET base layer, and electrolytically. 12.5 μm single wall thickness gold outer layer made by

The first catheter includes a proximal end having a hub containing a port for infusing fluid and a distal end generally opposite the proximal end, the distal end of the first catheter having three It is joined to the proximal end of a male tubular structure having four arms and tabs. The distal end of the male tubular structure is operably connected to a female tubular structure that is joined to the proximal neck of the removable balloon. The distal end of the first catheter further includes a fluoroscopic marker band. The first catheter hub also includes a rotating valve block configured to secure the first catheter hub to the second catheter shaft. A second catheter includes a proximal end having a hub containing a port for receiving a 0.014 inch guidewire and an open distal end. The second catheter further includes two fluoroscopic marker bands to facilitate placement and removal of the first elongated body. The second catheter is longer than the first catheter. The proximal portion of the second catheter passes through the hub of the first catheter and is secured to the hub of the first catheter by a rotating valve block. A central portion of the second catheter passes through the lumen of the first catheter. The distal portion of the second catheter is pleated and passes through the proximal neck opening of the folded detachable balloon, the central void, the distal neck opening, and the telescoping catheter segment. , extends distally to the distal end of the telescoping catheter segment at the distal neck of the detachable balloon. The inner surface of the first catheter and the outer surface of the second catheter allow passage of a fluid medium from the proximal end of the first catheter to the distal end of the first catheter and into the central void. defines the lumen of the A lumen of the second catheter defines a second lumen.

The physician advances the needle into the right femoral artery of a patient with a terminal saccular aneurysm of the basilar artery and retrogradely advances a 0.035 inch guidewire into the artery. The needle is removed and a 6Fr introducer sheath is placed in the right femoral artery. A 6 Fr guide catheter with a Tuohy-Borst adapter is inserted through the introducer sheath and advanced over the guidewire to the origin of the right vertebral artery. A standard digital subtraction angiogram is performed to confirm the size of the aneurysm. The aneurysm neck diameter measures 6 mm, the aneurysm width and depth 9 mm, and the aneurysm height 12 mm. The 0.035 inch guidewire is removed and a 300 cm 0.014 inch guidewire is inserted and advanced until its tip is within the aneurysm sac. The physician removes residual air from the removable balloon catheter, forms pleats, and advances the folded removable balloon over the guidewire until it is centered in the aneurysm sac. An inflation device filled with a mixture of 50% saline and 50% radiocontrast (by volume) was attached to the inflation port of the first catheter, and the inflation device was used to dispense the saline and contrast. The mixture is injected through the lumen of the first catheter into the central void of the balloon at a pressure of 5 atmospheres, resulting in full expansion of the balloon. The physician then removes the expanded removable balloon by pulling on the assembly of the first and second catheters until the proximal surface of the expanded removable balloon contacts the neck of the aneurysm. pull back. Radiographic injection through a 6 Fr guide catheter using a Tuohy-Borst sidearm confirms neck occlusion of the aneurysm with the inflated removable balloon. The physician opens a valved rotation lock in the hub of the first catheter to allow movement of the second catheter and fills the tip of the second catheter with an inflated removable balloon over the guidewire. Advance to the distal end of the aneurysm sac where there is no sac while maintaining the position of the inflated removable balloon and first catheter. Remove the 0.014 inch guidewire. dilated detachable by injecting a radiocontrast agent through the lumen of the second catheter, into the hub of the second catheter, and into the lumen of the vein distal to the dilated detachable balloon; Occlusion of the aneurysm by the balloon is confirmed. The physician then selects a second medical device comprising a first elongated body 70 cm in length comprising a coiled platinum wire joined to a second elongated body comprising a pusher wire. The first elongate body has a secondary diameter of 0.014 inches and includes a single 4 mm tertiary loop at the distal end, the remainder of the first elongate body having no tertiary shape when relevant. . The first elongated body is joined to the second elongated body (pusher wire) by mechanical attachment. The guidewire is removed from the lumen of the second catheter and the first elongated body is inserted into the lumen of the second catheter and advanced into the aneurysm sac under fluoroscopy. The physician advances the entire 70 cm of the first expandable body into the aneurysm sac using visual markings on the second elongated body of the second medical device for guidance. Injection of radiocontrast through a 6Fr guide catheter using the side arm of the Tuohy-Borst adapter resulted in occlusion of the aneurysm neck with the dilated removable balloon and dilated removable balloon and occlusion of the aneurysm. Proper placement of the elongate body of 1 is confirmed. The physician places the proximal end of the second elongated body of the second medical device into a handle provided on the second medical device, removes the first elongated body from the second elongated body, and removes the first elongated body from the second elongated body. Remove the second elongated body from. The physician then withdraws the tip of the second catheter until it is proximate the connection of the male and female tubular structures, breaking the connection between the male and female structures. The physician then uses a marker band on each catheter and a radiopaque female tubular structure bonded to the proximal neck of the removable balloon to confirm separation. The first and second catheters are withdrawn from the patient, leaving the balloon and first elongated body in the aneurysm sac. By injection of a radiocontrast agent through a 6 Fr guide catheter using the side arm of the Tuohy-Borst adapter, by an expanded removable balloon, and by appropriate injection of the expanded removable balloon and the first elongated body. Placement confirms complete occlusion of the aneurysm neck and sac. The physician then removes the right femoral artery introducer sheath and seals the hole in the right femoral artery with a closure device, successfully occluding the saccular aneurysm. Over the next few months, the elongated body within the central void of the balloon helps the balloon resist deflation, compression, or compaction. A thin outer layer of gold on the surface of the balloon induces a complete layer of new endothelium on the blood-contacting surface of the balloon that completely seals the neck of the aneurysm, and a capsule of tissue that holds the balloon in place. induce formation.

Example 29 Treatment of the Gastroduodenal Artery Using a Removable Flexible Metal-Coated Polymer Balloon Catheter and a Single Elongated Body
A removable balloon catheter (or A first medical device) is provided.

The removable balloon has a proximal neck and a distal neck. The female tubular structure is bonded to the proximal neck of a removable flexible metallized polymer balloon. A distal portion of the female tubular structure protrudes into the central void of the balloon. A telescoping catheter segment with proximal and distal marker bands is joined to the distal neck of the removable balloon. A proximal portion of the retractable catheter segment protrudes into the central void of the removable balloon. Excluding the proximal and distal neck lengths, the removable balloon has a diameter of 4 mm (measured in a plane parallel to the second axis) and a length of 6.8 mm (parallel to the first axis). measured on a plane). The proximal region 110 and distal region 120 of the removable balloon are conical with a cone angle of 45°. The wall of the removable balloon comprises an inner layer of PET with a single wall thickness of 10 μm made by blow molding and an outer layer of gold with a single wall thickness of 1000 Å made by sputter deposition on the outer surface of the PET base layer.

The first catheter includes a hub in which the distal end of the first catheter includes a port for infusing fluid, a proximal end, and a distal end generally opposite the proximal end, the three Attached to the proximal end of a male tubular structure having arms and tabs. The distal end of the male tubular structure is joined to a female tubular structure operably joined to the proximal neck of the removable balloon. Additionally, the distal end of the first catheter includes a fluoroscopic marker band. The first catheter hub also includes a rotating valve block configured to secure the first catheter hub to the second catheter shaft. A second catheter includes a proximal end having a hub containing a port for receiving a 0.014 inch guidewire and an open distal end. The second catheter further includes two fluoroscopic marker bands to facilitate placement and removal of the first elongate body. The second catheter is longer than the first catheter. The proximal portion of the second catheter passes through the hub of the first catheter and is secured to the hub of the first catheter by a rotating valve block. The intermediate portion of the second catheter passes through the lumen of the first catheter. The distal portion of the second catheter is pleated and passed through the proximal neck opening, the central void, the distal neck opening, and the telescoping catheter segment of the folded detachable balloon, and detachable. It extends distally to the distal end of the distal neck telescoping catheter segment of the possible balloon. The inner surface of the first catheter and the outer surface of the second catheter permit the fluid medium to pass from the proximal end of the first catheter to the distal end of the first catheter and enter the central void of the removable balloon. To enable, define a first lumen. A lumen of the second catheter defines a second lumen.

Physicians advance a needle into the right femoral artery and retrograde a 0.035 inch guidewire in patients with liver metastases from liver cancer who are scheduled for radioembolization. The needle is removed and a 6Fr introducer sheath is placed in the right femoral artery. A 6 Fr guide catheter with a Tuohy-Borst adapter is inserted into the introducer sheath, advanced over the guidewire, and used to engage the proximal origin of the celiac artery. Standard digital subtraction angiography is performed and the diameter of the gastroduodenal artery is measured at 3 mm. The 0.035 inch guidewire is removed and a 300 cm 0.014 inch guidewire is inserted and advanced through the gastroduodenal artery into the distal superior mesenteric artery. The physician removes residual air from the removable balloon catheter, forms pleats, and advances it over the guidewire until the proximal end of the folded removable balloon is positioned at the origin of the gastroduodenal artery. . An inflation device filled with a mixture of 50% saline and 50% radiocontrast (by volume) is attached to the inflation port of the first catheter and the inflation device is used to mix the saline and contrast. is injected through the lumen of the first catheter into the central void of the balloon at a pressure of 2 atmospheres, resulting in full inflation of the balloon. Occlusion of the gastroduodenal artery by the inflated removable balloon is confirmed by injecting a radiocontrast agent through a 6Fr guide catheter using a Tuohy-Borst sidearm. The physician then removes the second medical device provided with the detachable balloon catheter as a kit, the second medical device being a coiled platinum wire bonded to a second elongated body containing a pusher wire. It includes a 20 cm long first elongated body that includes a wire. The first elongate body has a secondary diameter of 0.014 inches and includes a single 4 mm tertiary loop at the distal end, the remainder of the first elongate body having no tertiary shape when relevant. . The first elongated body is joined to the second elongated body (pusher wire) by mechanical attachment. The guidewire is removed from the lumen of the second catheter and the first elongated body is inserted into the lumen of the second catheter and advanced until the distal 4mm loop is distally advanced to the tip of the second catheter. Let Using fluoroscopy, the physician locates the distal portion of the first elongated body of the second medical device adjacent the expanded removable balloon and in the lumen of the distal gastroduodenal artery. Confirmed to do. The physician opens the valved rotation lock in the hub of the first catheter to allow movement of the second catheter and, under fluoroscopy, inserts the second catheter into the central cavity of the detachable balloon with its tip expanded. and proximal to the proximal portion of the telescoping catheter segment coupled to the distal neck of the expanded removable balloon, while removing the expanded removable balloon and the first catheter. The position of is fixed and remains unchanged. The physician advances the remainder of the first expandable body into the central void of the expanded removable balloon using the fluoroscopic marker band on the second catheter for guidance. Occlusion of the gastroduodenal artery with the dilated removable balloon and the dilated removable balloon with the first by injecting a radiocontrast agent through the 6 Fr guide catheter using the side arm of the Tuohy-Borst adapter. Proper placement of the elongate body is confirmed. The physician places the proximal end of the second elongated body of the second medical device into the handle provided in the kit containing the removable balloon catheter and the second medical device and pushes the first elongated body. is removed from the second elongated body and the second elongated body is removed from the patient. The physician then withdraws the tip of the second catheter until it is proximate the connection of the male and female tubular structures, breaking the connection between the male and female structures. The physician then performs dilated removal using a marker band on each catheter and a radiopaque female tubular structure bonded to the proximal neck of the removable balloon to confirm separation. The first and second catheters are withdrawn from the patient leaving the balloon and first elongated body in the gastroduodenal artery. Complete occlusion of the gastroduodenal artery with an inflated removable balloon and with an inflated removable balloon by injecting a radiocontrast agent through a 6 Fr guide catheter using the side arm of the Tuohy-Borst adapter. Proper placement of the first elongated body is confirmed. The physician then removes the right femoral artery introducer sheath and closes the hole in the right femoral artery with a closure device, successfully occluding the gastroduodenal artery. Over the next few months, the elongated body within the central void of the balloon helps the balloon resist deflation, compression, or compaction. A thin gold outer layer on the surface of the balloon seals a portion of the artery and induces the formation of a capsule of tissue that holds the balloon in place.

(Example 30: Treatment of the gastroduodenal artery using a detachable metal balloon catheter)
A detachable balloon catheter (or first medical device) includes a pleated and folded detachable metal balloon and a catheter assembly including a first catheter, a second catheter and a third catheter. provided inclusive.

The removable balloon has a proximal neck and a distal neck. The outer surface of the distal end of the elastomeric tubular segment is bonded to the inner surface of the proximal neck of the removable balloon. The distal end of the first catheter is inserted into the proximal end of the elastomeric tubular segment to form a friction fit. The inner surface of the proximal portion of the distal nosecone is joined to the outer surface of the distal end of the distal neck of the removable balloon. The distal nosecone includes a resilient bulb and two spacers, one proximal and one distal, forming a friction fit. Excluding the length of the proximal and distal necks, the removable balloon has a diameter of 4 mm (measured in a plane parallel to the second axis) and a length of 6.8 mm (measured in a plane parallel to the first axis). (measured in parallel planes). The proximal region 110 and distal region 120 of the removable balloon are conical with a cone angle of 45°. The wall of the removable balloon comprises an inner layer of PET with a single wall thickness of 10 μm made by blow molding and an outer layer of gold with a single wall thickness of 1000 Å made by sputter deposition on the outer surface of the PET base layer.

A first catheter includes a proximal end having a hub containing a port for infusing fluid and a distal end operably coupled to the proximal end of the elastomeric tubular segment portion of the proximal neck assembly. I'm in. The distal end of the first catheter further includes a fluoroscopic marker band. The first catheter hub also includes a rotating valve block configured to secure the first catheter hub to the second catheter shaft. A second catheter includes a proximal end having a hub containing a port for receiving a 0.014 inch guidewire and an open distal end. The second catheter further includes a fluoroscopic marker at its distal end. The third catheter hub also includes a rotating valve block configured to secure the third catheter hub to the first catheter shaft. The distal end of the third catheter further includes a fluoroscopic marker band.

The first catheter is longer than the third catheter. The proximal portion of the first catheter passes through the hub of the third catheter and is secured to the hub of the third catheter by a rotating valve block. The intermediate portion of the first catheter passes through the lumen of the third catheter. The distal portion of the first catheter extends distally to the distal end of the third catheter. The inner surface of the third catheter and the outer surface of the first catheter permit passage of a fluid medium containing a radiocontrast agent solution from the proximal end of the third catheter to the distal end of the third catheter, defines a third lumen such that it can exit the third catheter and enter the arterial or venous lumen.

The second catheter is longer than the first catheter. The proximal portion of the second catheter passes through the hub of the first catheter and is secured to the hub of the first catheter by a rotating valve block. A central portion of the second catheter passes through the lumen of the first catheter. The distal portion of the second catheter forms pleats and includes a proximal neck opening, a central cavity, a distal neck opening, a distal neck radiopaque tubular shape, and a folded removable balloon. It passes through the structure and the friction fit valve and spacer of the distal nosecone and extends distally to the distal end of the distal nosecone of the removable balloon. A portion of the shaft of the second catheter is operatively coupled to the elastomeric valve of the distal nosecone of the removable balloon by a friction fit. The inner surface of the first catheter and the outer surface of the second catheter allow fluid medium to pass from the proximal end of the first catheter to the distal end of the first catheter and enter the central cavity of the removable balloon. defining a first lumen that allows A lumen of the second catheter defines a second lumen.

Physicians advance a needle into the right femoral artery and retrogradely advance a 0.035 inch guidewire into the artery in patients with liver metastases from liver cancer who are scheduled for radioembolization. The needle is removed and a 6Fr introducer sheath is placed in the right femoral artery. A 6 Fr guide catheter with a Tuohy-Borst adapter is inserted into the introducer sheath, advanced over the guidewire, and used to engage the proximal origin of the celiac artery. Standard digital subtraction angiography is performed and the diameter of the gastroduodenal artery is measured at 3 mm. The 0.035 inch guidewire is removed and a 300 cm 0.014 inch guidewire is inserted and advanced through the gastroduodenal artery into the distal superior mesenteric artery. The physician removes residual air from the removable balloon catheter, forms pleats, and advances it over the guidewire until the proximal end of the folded removable balloon is at the origin of the gastroduodenal artery. An inflation device filled with a mixture of 50% saline and 50% radiocontrast (by volume) is attached to the inflation port of the first catheter and the inflation device is used to mix the saline and contrast. through the lumen of the first catheter and into the central void of the balloon at a pressure of 4 atmospheres. Resulting in full inflation of the balloon. The physician opens the rotating valve lock on the hub of the third catheter and advances the tip of the third catheter forward until it enters the celiac artery, but the first catheter, the second catheter, and the removable balloon remains fixed in place. The physician closes the rotary valve lock on the hub of the third catheter. Occlusion of the gastroduodenal artery by the inflated removable balloon is confirmed by injecting a radiocontrast agent into the hub of the third catheter. The physician opens the rotating valve lock on the hub of the third catheter and advances the tip of the third catheter forward until it contacts the proximal end of the elastomeric tubular segment. While securing the third catheter in place, the physician withdraws the first and second catheter assembly, leaving the removable balloon, third catheter, and guidewire in place. . Injection of radiocontrast into the hub of the third catheter confirms closure of the distal nosecone elastomeric valve and complete occlusion of the gastroduodenal artery by the dilated removable balloon. The doctor removes the third catheter and guidewire from the patient. The physician then removes the right femoral artery introducer sheath and closes the hole in the right femoral artery with a closure device, successfully occluding the gastroduodenal artery. Over the next few months, the elongated body within the central void of the balloon helps the balloon resist deflation, compression, or compaction, and a thin outer layer of gold on the surface of the balloon seals the segments of the artery to the balloon. triggers the formation of a capsule of tissue that holds the tissue in place.

Example 31 Treatment of Left Ovarian Vein Using a Detachable Flexible Metallized Polymer Balloon Catheter with Distal Neck Retention Structure and Single Elongated Body
A removable balloon catheter (or first medical device) comprises a pleated, folded removable flexible metal-coated polymer balloon, a first catheter, a second catheter and a first medical device. and a catheter assembly containing three catheters.

The removable balloon has a proximal neck and a distal neck. A female tubular structure is bonded to the proximal neck of a removable flexible metallized polymer balloon. A distal portion of the female tubular structure protrudes into the central void of the balloon. A telescoping catheter segment with proximal and distal marker bands is joined to the distal neck of the removable balloon. A proximal portion of the retractable catheter segment protrudes into the central void of the removable balloon. The inner surface of the proximal ring of the nitinol retention structure is bonded to the outer surface of the distal neck of the removable balloon. The arms and hooks of the nitinol retention structure extend distally from the proximal ring. Excluding the proximal and distal neck lengths, the removable balloon has a diameter of 10 mm (measured in a plane parallel to the second axis) and a length of 16.8 mm (parallel to the first axis). measured on a plane). The proximal and distal regions of the removable balloon are conical with a cone angle of 45°. The wall of the removable balloon comprises an inner layer of PET with a single wall thickness of 20 μm made by blow molding and an outer layer of gold with a single wall thickness of 1000 Å made by sputter deposition on the outer surface of the PET base layer.

A first catheter includes a proximal end having a hub containing a port for infusing fluid and a distal end operably coupled to the proximal end of the elastomeric tubular segment portion of the proximal neck assembly. I'm in. The distal end of the first catheter further includes a fluoroscopic marker band. The first catheter hub also includes a rotating valve block configured to secure the first catheter hub to the second catheter shaft. A second catheter includes a proximal end having a hub containing a port for receiving a 0.014 inch guidewire and an open distal end. The second catheter further includes a fluoroscopic marker at its distal end. The distal end of the third catheter has a side hole configured to allow fluid injected into the third catheter to exit the lumen of the catheter. The third catheter hub also includes a rotating valve block configured to secure the third catheter hub to the first catheter shaft. The distal end of the third catheter further includes a fluoroscopic marker band.

The proximal portion of the first catheter passes through the hub of the third catheter and is secured to the hub of the third catheter by a rotating valve block. The intermediate and distal portions of the first catheter are within the lumen of the third catheter. For the proximal portion and the intermediate portion of the third catheter, the inner surface of the third catheter and the outer surface of the first catheter are such that the fluid medium containing the radiocontrast agent solution passes from the proximal end of the third catheter to the distal end of the third catheter. defining a third lumen such that it can pass through to the posterior extremity and, when used in vivo, exit the third catheter and enter the lumen of an artery or vein; . For the distal portion of the third catheter, the outer surface of the folded removable balloon forming pleats with the inner surface of the third catheter, the retaining structure, and the second catheter are in a fluid medium containing a radiocontrast solution. from the proximal end of the third catheter to the distal end of the third catheter, and when used in vivo, can exit the third catheter and enter the lumen of an artery or vein. As can be, a third lumen is defined. The arms and hooks of the nitinol retention structure extend distally from the proximal ring and are completely covered and constrained by the third catheter.

The second catheter is longer than the first and third catheters. The proximal portion of the second catheter passes through the hub of the first catheter and is secured to the hub of the first catheter by a rotating valve block. A central portion of the second catheter passes through the lumen of the first catheter. A distal portion of the second catheter passes through the proximal neck opening, the central void, and the distal neck opening and extends distally to the distal end of the third catheter. The inner surface of the first catheter and the outer surface of the second catheter permit passage of the fluid medium from the proximal end of the first catheter to the distal end of the first catheter and into the central void of the removable balloon. An enabling first lumen is defined. A lumen of the second catheter defines a second lumen.

A physician advances a needle into the right femoral vein of a patient with pelvic pain and left ovarian varices and advances a 0.035 inch guidewire into the vein in an anterior direction. The needle is removed and a 7Fr introducer sheath is placed in the right femoral vein. A 7Fr guide catheter with a Tuohy-Borst adapter is inserted through the introducer sheath and advanced over the guidewire to the distal portion of the left ovarian dilated vein. A standard digital subtraction angiography is performed and the diameter of the left ovary is measured to be 7 mm. The 0.035 inch guidewire is removed and a 300 cm long 0.014 inch guidewire is inserted and advanced into the distal left ovarian vein. The physician removes residual air from the detachable balloon catheter, forms pleats, and advances it over the guidewire until the proximal end of the folded detachable balloon is positioned in the distal left ovarian vein. . The physician opens the rotating valve lock in the hub of the third catheter, forms pleats with the retention structure, and pulls back the tip of the third catheter until both the folded balloons are exposed, but not the first catheter, the second catheter. The catheter and removable balloon remain fixed in place. The physician closes the rotary valve lock on the hub of the third catheter. A removable balloon position and retention structure that is pleated and folded by injecting a radiocontrast agent into the hub of the third catheter and the gentle tabs of the first catheter. Proper engagement of the hooks on the vein wall is confirmed. An inflation device filled with a mixture of 50% saline and 50% radiocontrast (by volume) was attached to the inflation port of the first catheter, and the inflation device was used to dispense the saline and contrast. The mixture is injected through the lumen of the first catheter into the central void of the balloon at a pressure of 2 atmospheres, resulting in full inflation of the balloon. left ovarian vein with the dilated removable balloon by injecting a radiocontrast agent through the lumen of the third catheter into the hub of the third catheter and into the lumen of the vein adjacent to the dilated removable balloon. Occlusion is confirmed. Remove the 0.014 inch guidewire. Occlusion of the left ovarian vein is confirmed by injecting a radiocontrast agent through the lumen of the second catheter, into the hub of the second catheter, and into the venous lumen distal to the inflated removable balloon. . The physician then removes the second medical device provided with the detachable balloon catheter as a kit, the second medical device comprising a coiled platinum wire coupled to a second elongated body including a pusher wire. a first elongated body 100 cm long. The first elongate body has a secondary diameter of 0.014 inches and includes a single 4 mm tertiary loop at the distal end, the remainder of the first elongate body having no tertiary shape when relevant. . The first elongated body is joined to the second elongated body (pusher wire) by mechanical attachment. The guidewire is removed from the lumen of the second catheter and the first elongated body is inserted into the lumen of the second catheter and advanced until the distal 4mm loop extends distally to the tip of the second catheter. Let Using fluoroscopy, the physician locates the distal portion of the first elongated body of the second medical device adjacent to and distal to the expanded removable balloon in the lumen of the left ovarian vein. Confirmed to do. The physician opens a valved rotation lock in the hub of the first catheter to allow movement of the second catheter and, under fluoroscopy, inserts the second catheter into the central cavity of the detachable balloon with its tip expanded. withdraw the second catheter until it is at and proximal to the proximal portion of the telescoping catheter segment coupled to the distal neck of the inflated removable balloon, while the second catheter is inflated The positions of the removable balloon, first catheter, and third catheter are fixed and left unchanged. The physician advances the remainder of the first expandable body into the central void of the expanded removable balloon using the fluoroscopic marker band on the second catheter for guidance. Left ovarian vein with the detachable balloon dilated by injection of a radiocontrast agent through the lumen of the third catheter into the lumen of the vein adjacent to the hub of the third catheter and the dilated detachable balloon occlusion and proper placement of the expanded removable balloon and first elongated body are confirmed. The physician places the proximal end of the second elongated body of the second medical device into a handle provided in a kit that includes the removable balloon catheter and the second medical device, and pushes the first elongated body. The body is detached from the second elongated body and the second elongated body is removed from the patient. The physician then withdraws the tip of the second catheter until it is proximate the connection of the male and female tubular structures, breaking the connection between the male and female structures. The physician then performs dilated removal using a marker band on each catheter and a radiopaque female tubular structure bonded to the proximal neck of the removable balloon to confirm separation. The first and second catheters are withdrawn from the patient, leaving the balloon and first elongated body in the left ovarian vein. The left ovary with the dilated removable balloon by injecting a radiocontrast agent through the lumen of the third catheter into the hub of the third catheter and into the lumen of the vein adjacent to the dilated removable balloon. Occlusion of the vein and proper placement of the inflated removable balloon and first elongated body are confirmed. The physician removes the third catheter, then removes the right femoral vein introducer sheath and manually applies pressure to occlude the hole in the right femoral vein, successfully occluding the left ovarian vein. Over the next several months, the elongated body within the central void of the balloon helped the balloon resist deflation, compression, or compaction, and the thin outer layer of gold on the balloon's surface occluded the vein segments and provided Inducing the formation of a tissue capsule that holds the balloon in place.

Example 32 Treatment of Gastroesophageal Venous Varices Using a Detachable Flexible Metal-Coated Polymer Balloon Catheter with a Proximal Neck Retention Structure and a Single Elongated Body
A removable balloon catheter (or first medical device) comprises a pleated, folded removable flexible metal-coated polymer balloon, a first catheter, a second catheter and a first medical device. a catheter assembly including three catheters.

The removable balloon has a proximal neck and a distal neck. A female tubular structure is bonded to the proximal neck of a removable flexible metallized polymer balloon. A distal portion of the female tubular structure protrudes into the central void of the balloon. A telescoping catheter segment with proximal and distal marker bands is joined to the distal neck of the removable balloon. A proximal portion of the retractable catheter segment protrudes into the central void of the removable balloon. The inner surface of the distal ring of the nitinol retention structure is bonded to the outer surface of the proximal neck of the removable balloon. The elongated arms and barbs (or barbs) of the nitinol retention structure extend distally from the distal ring and then come together at the proximal ring. Excluding the proximal and distal neck lengths, the removable balloon has a diameter of 10 mm (measured in a plane parallel to the second axis) and a length of 16.8 mm (parallel to the first axis). measured on a plane). The proximal and distal regions of the removable balloon are conical with a cone angle of 45°. The wall of the removable balloon comprises an inner layer of PET with a single wall thickness of 20 μm made by blow molding and an outer layer of gold with a single wall thickness of 1000 Å made by sputter deposition on the outer surface of the PET base layer.

A first catheter includes a proximal end having a hub containing a port for infusing fluid, and a distal end operably coupled to the proximal end of the elastomeric tubular segment portion of the proximal neck assembly. . The distal end of the first catheter further includes a fluoroscopic marker band. The first catheter hub also includes a rotating valve block configured to secure the first catheter hub to the second catheter shaft. A second catheter includes a proximal end having a hub containing a port for receiving a 0.014 inch guidewire and an open distal end. The second catheter further includes a fluoroscopic marker at its distal end. A third catheter includes a proximal end having a hub containing a port for injection of radiocontrast agent and an open distal end. The distal end of the third catheter has a side hole configured to allow fluid injected into the third catheter to exit the catheter lumen. The third catheter hub also includes a rotating valve block configured to secure the third catheter hub to the first catheter shaft. The distal end of the third catheter further includes a fluoroscopic marker band.

The proximal portion of the first catheter passes through the hub of the third catheter and is secured to the hub of the third catheter by a rotating valve block. The intermediate and distal portions of the first catheter are within the lumen of the third catheter. For the proximal portion and the intermediate portion of the third catheter, the inner surface of the third catheter and the outer surface of the first catheter are immersed in a fluid medium containing a radiocontrast agent solution from the proximal end of the third catheter to the third catheter. Allow passage to the distal end of the catheter and define a third lumen so that when used in vivo it can exit the third catheter and enter the lumen of an artery or vein. . For the distal portion of the third catheter, the inner surface of the third catheter and the outer surface of the retention structure, the pleated and folded removable balloon, and the second catheter are placed in a fluid medium containing a radiographic solution. Allows passage from the proximal end of the three catheters to the distal end of the third catheter, and when used in vivo it can exit the third catheter and enter the lumen of an artery or vein so as to define a third lumen. A nitinol retention structure bonded to the proximal neck of the removable balloon is completely covered and constrained by a third catheter.

The second catheter is longer than the first and third catheters. The proximal portion of the second catheter passes through the hub of the first catheter and is secured to the hub of the first catheter by a rotating valve block. A central portion of the second catheter passes through the lumen of the first catheter. A distal portion of the second catheter passes through the proximal neck opening, the central void, and the distal neck opening and extends distally to the distal end of the third catheter. The inner surface of the first catheter and the outer surface of the second catheter permit the fluid medium to pass from the proximal end of the first catheter to the distal end of the first catheter and enter the central void of the removable balloon. An enabling first lumen is defined. A lumen of the second catheter defines a second lumen.

Under fluoroscopy, the physician advances the needle into the liver of a patient with cirrhosis and bleeding gastroesophageal varices to find the bifurcation of the right hepatic vein. The physician retrogradely advances a 0.035 inch guidewire into the hepatic vein and inserts a 7 Fr introducer sheath into the hepatic vein. A flexible, curved needle is then inserted through a 7 Fr introducer sheath and advanced from the hepatic vein bifurcation through the liver parenchyma to the portal vein branch. The physician retrogradely advances a 0.035 inch guidewire into the portal vein, removes the needle, and places a stent into the vein from the portal vein through the liver parenchyma to lower blood pressure in the portal vein. A 5 Fr diagnostic catheter is then advanced into the largest gastroesophageal collateral branch originating from the portal vein over a 0.035 inch guidewire. The 0.035 inch guidewire is removed, a 300 cm 0.014 inch guidewire is inserted and advanced to the gastroesophageal adrenal gland, and the 5 Fr diagnostic catheter is removed. The physician removes residual air from the removable balloon catheter, forms pleats, and advances it over the guidewire until the proximal end of the folded removable balloon is positioned in the gastroesophageal collateral vein. The physician opens the rotating valve lock in the hub of the third catheter, forms pleats, and pulls back the tip of the third catheter until both the folded balloon and retention structure are exposed, while the first catheter, the 2 catheters, and the removable balloon remain fixed in place. The physician closes the rotary valve lock on the hub of the third catheter. Injection of a radio-contrast agent into the hub of the third catheter and the gentle tabs of the first catheter to form pleats, the position of the folded removable balloon and the position of the barb of the retention structure to the vein wall. Proper engagement is confirmed. An inflation device filled with a mixture of 50% saline and 50% radiocontrast (by volume) was attached to the inflation port of the first catheter, and the inflation device was used to dispense the saline and contrast. The mixture is injected through the lumen of the first catheter into the central void of the balloon at a pressure of 2 atmospheres, resulting in full inflation of the balloon. Gastroesophageal esophagus with dilated removable balloon by injecting a radio-contrast agent through the lumen of the third catheter into the hub of the third catheter and into the lumen of the vein adjacent to the dilated removable balloon Check for collateral vein occlusion. Remove the 0.014 inch guidewire. Left ovary with dilated detachable balloon by injecting a radiocontrast agent through the lumen of the second catheter, into the hub of the second catheter, and into the venous lumen distal to the dilated detachable balloon. Venous occlusion is confirmed. The physician then removes a second medical instrument provided with a detachable balloon catheter as a kit, the second medical device being a coiled platinum wire coupled to a second elongated body including a pusher wire. A 100 cm long first elongated body comprising: The first elongate body has a secondary diameter of 0.014 inches and includes a single 4 mm tertiary loop at the distal end, the remainder of the first elongate body having no tertiary shape when relevant. . The first elongated body is joined to the second elongated body (pusher wire) by mechanical attachment. The guidewire is removed from the lumen of the second catheter and the first elongated body is inserted into the lumen of the second catheter until the distal 4mm loop advances distally to the tip of the second catheter. move forward. The physician uses fluoroscopy to determine if the distal portion of the first elongated body of the second medical device is adjacent the expanded removable balloon and into the lumen of the distal gastroesophageal accessory vein. make sure it's positioned. The physician opens the valved rotation lock in the hub of the first catheter to allow movement of the second catheter and, under fluoroscopy, inserts the second catheter into the central cavity of the detachable balloon with its tip expanded. and is proximal to the proximal portion of the telescoping catheter segment coupled to the distal neck of the expanded removable balloon, while removing the expanded removable balloon, the second The position of one catheter, and the third catheter is fixed and remains unchanged. The physician advances the remainder of the first expandable body into the central void of the expanded removable balloon using the fluoroscopic marker band on the second catheter for guidance. Gastroesophageal esophagus with dilated removable balloon by injecting a radio-contrast agent through the lumen of the third catheter into the hub of the third catheter and into the lumen of the vein adjacent to the dilated removable balloon Occlusion of the collateral vein and proper placement of the inflated removable balloon and first elongated body are confirmed. The physician places the proximal end of the second elongated body of the second medical device into the handle provided in the kit containing the removable balloon catheter and the second medical instrument, and pushes the first elongated body into the handle. Detaching from the second elongated body and removing the second elongated body from the patient. The physician then withdraws the tip of the second catheter until it is proximate the connection of the male and female tubular structures, breaking the connection between the male and female structures. The physician then performs dilated removal using a marker band on each catheter and a radiopaque female tubular structure bonded to the proximal neck of the removable balloon to confirm separation. The first and second catheters are withdrawn from the patient, leaving the balloon and first elongated body in the gastroesophageal collateral vein. Gastroesophageal esophagus with dilated removable balloon by injecting a radio-contrast agent through the lumen of the third catheter into the hub of the third catheter and into the lumen of the vein adjacent to the dilated removable balloon Occlusion of the collateral vein and proper placement of the inflated removable balloon and first elongated body are confirmed. The physician removes the third catheter, then removes the introducer sheath from the liver, seals the hole in the liver with pledgets, successfully lowers the portal blood pressure, and removes the major gastroesophageal side. The accessory vein was occluded. Over the next few months, the elongated body within the central void of the balloon helps the balloon resist deflation, compression, or compaction. A thin outer layer of gold on the balloon surface seals off a portion of the vein and induces the formation of a tissue capsule that holds the balloon in place.

Example 33 Treatment of the Left Atrial Appendage Using a Removable Flexible Metal-Coated Polymer Balloon Catheter with a Distal Neck Retention Structure and a Single Elongated Body
A removable balloon catheter (or first medical device) comprises a pleated, folded removable flexible metal-coated polymer balloon, a first catheter, a second catheter and a first medical device. and a catheter assembly containing three catheters.

The removable balloon has a proximal neck and a distal neck. A female tubular structure is bonded to the proximal neck of a removable flexible metallized polymer balloon. A distal portion of the female tubular structure protrudes into the central void of the balloon. A telescoping catheter segment with proximal and distal marker bands is joined to the distal neck of the removable balloon. A proximal portion of the retractable catheter segment protrudes into the central void of the removable balloon. The inner surface of the proximal ring of the nitinol retention structure is bonded to the outer surface of the distal neck of the removable balloon. The arms and hooks of the nitinol retention structure extend distally from the proximal ring. Excluding the proximal and distal neck lengths, the removable balloon has a diameter of 26 mm (measured in a plane parallel to the second axis) and a length of 32 mm (measured in a plane parallel to the first axis). be. Proximal region 110 and distal region 120 of removable balloon 10 are curvilinear. The wall of the removable balloon comprises an inner layer of PET with a single wall thickness of 30 μm made by blow molding and an outer layer of gold with a single wall thickness of 1000 Å made by sputter deposition on the outer surface of the PET base layer.

A first catheter includes a proximal end having a hub containing a port for infusing fluid, and a distal end operably coupled to the proximal end of the elastomeric tubular segment portion of the proximal neck assembly. . The distal end of the first catheter further includes a fluoroscopic marker band. The first catheter hub also includes a rotating valve block configured to secure the first catheter hub to the second catheter shaft. A second catheter includes a proximal end having a hub containing a port for receiving a 0.038 inch guidewire and an open distal end. The second catheter further includes a fluoroscopic marker at its distal end. The distal end of the third catheter has a side hole configured to allow fluid injected into the third catheter to exit the lumen of the catheter. The catheter also includes a rotating valve block configured to secure the hub of the third catheter to the shaft of the first catheter. The distal end of the third catheter further includes a fluoroscopic marker band.

The proximal portion of the first catheter passes through the hub of the third catheter and is secured to the hub of the third catheter by a rotating valve block. The central and distal portions of the first catheter are within the lumen of the third catheter. For the proximal portion and the intermediate portion of the third catheter, the inner surface of the third catheter and the outer surface of the first catheter are immersed in a fluid medium containing a radiocontrast agent solution from the proximal end of the third catheter to the third catheter. A third lumen is defined to allow passage to the distal end of the catheter so that it can exit the third catheter. For the distal portion of the third catheter, the outer surface of the folded removable balloon forming a pleat with the inner surface of the third catheter, the retention structure, and the second catheter are a fluid medium containing a radiocontrast agent solution. defines a third lumen to allow passage of from the proximal end of the third catheter to the distal end of the third catheter so that it can exit the third catheter. The arms and hooks of the nitinol retention structure extend distally from the proximal ring and are completely covered and constrained by the third catheter.

The second catheter is longer than the first and third catheters. The proximal portion of the second catheter passes through the hub of the first catheter and is secured to the hub of the first catheter by a rotating valve block. A central portion of the second catheter passes through the lumen of the first catheter. A distal portion of the second catheter passes through the proximal neck opening, the central void, and the distal neck opening and extends distally to the distal end of the third catheter. The inner surface of the first catheter and the outer surface of the second catheter permit the fluid medium to pass from the proximal end of the first catheter to the distal end of the first catheter and enter the central void of the removable balloon. An enabling first lumen is defined. A lumen of the second catheter defines a second lumen.

A physician advances a needle into the right femoral vein in a patient with atrial fibrillation with chronic anticoagulation contraindications and advances a 0.038 inch guidewire 300 cm long into the vein in an antegrade direction. The needle is removed and an 8Fr introducer sheath is inserted into the right femoral vein. An 8 Fr guide catheter with Tuohy-Borst adapter is inserted through the introducer sheath and advanced over the guidewire into the right atrium. Under transesophageal ultrasound guidance, a puncture is made in the interatrial septum, a serial fascial dilator is used to dilate the puncture tract, and an 8Fr guiding catheter is advanced into the left atrium. A guidewire is advanced deep into the left atrial appendage (LAA) using a 5 Fr diagnostic catheter. The diameter of the LAA was measured using transesophageal echocardiography and demonstrates a diameter of 20 mm near the neck. The physician removes residual air from the detachable balloon catheter, forms pleats, and inserts the guidewire until the proximal end of the folded detachable balloon is positioned in the LAA just distal to the neck of the LAA. move up. The physician opens the rotating valve lock in the hub of the third catheter, forms pleats with the retention structure, and pulls back the tip of the third catheter until both the folded balloons are exposed, but not the first catheter, the second catheter. , and the removable balloon remain fixed in place. The physician closes the rotary valve lock on the hub of the third catheter. Injection of a radiocontrast agent into the hub of the third catheter and the gentle tabs of the first catheter to form pleats to determine the position of the folded removable balloon and the hooking of the retention structure to the wall of the LAA. Proper engagement is confirmed. Transesophageal echocardiography is used for confirmation. An inflation device filled with a mixture of 50% saline and 50% radiocontrast (by volume) was attached to the inflation port of the first catheter, and the inflation device was used to dispense the saline and contrast. The mixture is injected through the lumen of the first catheter into the central void of the balloon at a pressure of 2 atmospheres, resulting in full inflation of the balloon. Occlusion of the LAA by the expanded removable balloon is achieved by injecting a radiocontrast agent through the lumen of the third catheter into the hub of the third catheter and into the lumen of the LAA adjacent to the expanded removable balloon. It is confirmed. Transesophageal echocardiography is used for confirmation. The physician then removes the second medical device provided with the detachable balloon catheter as a kit, the second medical device being a coiled platinum wire bonded to a second elongated body including a pusher wire. A 300 cm long first elongated body containing a. The first elongated body has a secondary diameter of 0.035 inches and includes a single 6mm tertiary loop at the distal end, the remainder of the first elongated body having no tertiary shape when relevant. . The first elongated body is joined to the second elongated body (pusher wire) by mechanical attachment. The physician opens a valved rotation lock in the hub of the first catheter to allow movement of the second catheter and, under fluoroscopy, places the second catheter in the center of the detachable balloon with its tip inflated. Withdrawing the expanded removable balloon until it is within the void and adjacent to the proximal portion of the distal neck-tied telescoping catheter segment while the expanded removable balloon is the first catheter. , and the position of the third catheter remain fixed and unchanged. The guidewire is removed from the lumen of the second catheter and the first elongated body is inserted into the lumen of the second catheter with the distal 6 mm loop in the central cavity of the expanded removable balloon. advance until it becomes The physician advances the remainder of the first expandable body into the central void of the expanded removable balloon using the fluoroscopic marker band on the second catheter for guidance. the LAA with the expanded removable balloon by injecting a radiocontrast agent through the lumen of the third catheter into the hub of the third catheter and into the lumen of the LAA adjacent to the expanded removable balloon; Occlusion and proper placement of the expanded removable balloon and first elongated body are confirmed. Transesophageal echocardiography is used for confirmation. The physician places the proximal end of the second elongated body of the second medical device into the handle provided in the kit containing the removable balloon catheter and the second medical instrument, and pushes the first elongated body into the handle. Detaching from the second elongated body and removing the second elongated body from the patient. The physician then withdraws the tip of the second catheter until it is proximate the connection of the male and female tubular structures, breaking the connection between the male and female structures. The physician then uses a marker band on each catheter and a radiopaque female tubular structure bonded to the proximal neck of the removable balloon to confirm separation. and withdraw the first and second catheters from the patient leaving the first elongated body in the LAA. the LAA with the expanded removable balloon by injecting a radiocontrast agent through the lumen of the third catheter into the hub of the third catheter and into the lumen of the LAA adjacent to the expanded removable balloon; Occlusion and proper placement of the inflated removable balloon and first elongated body are confirmed. Transesophageal echocardiography is used for confirmation. The physician removes the third catheter and the 8 Fr guide catheter, then removes the introducer sheath of the right femoral vein and applies manual pressure to seal the hole in the right femoral vein, successfully occluding the LAA. . Over the next few months, the elongated body within the central void of the balloon helps the balloon resist deflation, compression, or compaction. A thin outer layer of gold on the surface of the balloon induces a complete layer of new endothelium on the blood-contacting surface of the balloon, which completely seals the neck of the LAA and holds the balloon in place.

Example 34 Treatment of Aortic Valve Paravalvular Leak Using a Removable Flexible Metal-Coated Polymer Balloon Catheter and a Single Elongated Body
A detachable balloon catheter (or first medical device) is a catheter comprising a pleated, folded detachable flexible metal-coated polymer balloon and a first catheter and a second catheter provided, including assembly.

The removable balloon includes a proximal neck and a distal neck. A female tubular structure is bonded to the proximal neck of a removable flexible metallized polymer balloon. A distal portion of the female tubular structure protrudes into the central void of the balloon. A telescoping catheter segment with proximal and distal marker bands is joined to the distal neck of the removable balloon. A proximal portion of the retractable catheter segment protrudes into the central void of the removable balloon. Excluding the proximal and distal neck lengths, the removable balloon has a diameter of 6 mm (measured in a plane parallel to the second axis) and a length of 16 mm (measured in a plane parallel to the first axis). ). Proximal region 110 and distal region 120 of removable balloon 10 are curvilinear. The wall of the removable balloon comprises an inner layer of PET with a single wall thickness of 14 μm made by blow molding and an outer layer of gold with a single wall thickness of 1000 Å made by sputter deposition on the outer surface of the PET base layer.

A first catheter includes a proximal end having a hub containing a port for infusion of fluid and a distal end generally opposite the proximal end, the distal end of the first catheter having three arms. and the proximal end of a male tubular structure having tabs. The distal end of the male tubular structure is operably connected to a female tubular structure that is joined to the proximal neck of the removable balloon. The distal end of the first catheter further includes a fluoroscopic marker band. The first catheter hub also includes a rotating valve block configured to secure the first catheter hub to the second catheter shaft. A second catheter includes a proximal end having a hub containing a port for receiving a 0.014 inch guidewire and an open distal end. The second catheter further includes two fluoroscopic marker bands to facilitate placement and removal of the first elongated body. The second catheter is longer than the first catheter. The proximal portion of the second catheter passes through the hub of the first catheter and is secured to the hub of the first catheter by a rotating valve block. A central portion of the second catheter passes through the lumen of the first catheter. The distal portion of the second catheter is pleated and passed through the proximal neck opening, the central void, the distal neck opening, and the telescoping catheter segment of the folded detachable balloon, and detachable. It extends distally to the distal end of the distal neck telescoping catheter segment of the possible balloon. The inner surface of the first catheter and the outer surface of the second catheter are such that the fluid medium passes from the proximal end of the first catheter to the distal end of the first catheter and into the central void of the removable balloon. A first lumen is defined to allow for A lumen of the second catheter defines a second lumen.

A physician advances a needle into the right femoral artery of a patient who underwent transcatheter aortic valve replacement and now has a paravalvular leak. Retrogradely advance a 0.035 inch guidewire into the artery. The needle is removed and a 6Fr introducer sheath is placed in the right femoral artery. A 6 Fr guide catheter with a Tuohy-Borst adapter is inserted through the introducer sheath, advanced over the guidewire, and advanced into the left ventricle. A standard digital subtraction angiogram is performed to identify the paravalvular leakage pathway. The diameter of the paravalvular leak path is identified as 4 mm. The length of the paravalvular leak path is identified as 12 mm. The tip of a 6 Fr guide catheter is pulled back into the aorta just distal to the paravalvular leak and a 5 Fr diagnostic catheter and a 300 cm 0.014 inch guidewire are used to catheterize the paravalvular leak tract and guidewire. is placed in the left ventricle. Remove the 5 Fr diagnostic catheter. The physician removes residual air from the removable balloon catheter, forms pleats, places the distal end of the folded removable balloon just inside the left ventricle, and forms pleats and folds. Advance the removable balloon over the guidewire until the proximal end is positioned just inside the aorta. The inflation device is filled with the inflation port of the first catheter, and the inflation device is used to inject a mixture of saline and contrast agent at a pressure of 2 atmospheres through the lumen of the first catheter into the central void of the balloon, and brings a full expansion of Transesophageal neo-ultrasound is used to confirm complete occlusion of the paravalvular leak. The physician then removes the second medical device provided with the detachable balloon catheter as a kit, the second medical device being a coiled platinum wire bonded to a second elongated body including a pusher wire. an 80 cm long first elongated body containing a. The first elongate body has a secondary diameter of 0.014 inches and includes a single 4 mm tertiary loop at the distal end, the remainder of the first elongate body having no tertiary shape when relevant. . The first elongated body is joined to the second elongated body (pusher wire) by mechanical attachment. A physician opens a valved rotation lock in the hub of the first catheter to allow movement of the second catheter and, under fluoroscopy, inserts the second catheter into the central cavity of the detachable balloon with its tip expanded. The position of the expanded removable balloon and the first catheter is then pulled back into proximity with the proximal portion of the telescoping catheter segment that is within and coupled to the distal neck of the expanded removable balloon. It is fixed and remains unchanged. The guidewire is removed from the lumen of the second catheter and the first elongated body is inserted into the lumen of the second catheter and advanced until the distal 4 mm loop advances into the central void of the balloon. The physician then advances the remainder of the first expandable body into the central void of the expanded removable balloon using a fluoroscopic marker band on the second catheter for guidance. . Transesophageal echocardiography is used to confirm complete occlusion of the paravalvular leak. Fluoroscopy is used to confirm proper placement of the expanded removable balloon and first elongated body. The physician places the proximal end of the second elongated body of the second medical device into the handle provided in the kit containing the removable balloon catheter and the second medical device, and displaces the first elongated body. is removed from the second elongated body and the second elongated body is removed from the patient. The physician then withdraws the tip of the second catheter until it is proximate the connection of the male and female tubular structures, breaking the connection between the male and female structures. The physician then uses a marker band on each catheter and a radiopaque female tubular structure bonded to the proximal neck of the removable balloon to confirm separation. The first catheter and the second catheter are withdrawn from the patient leaving the balloon and first elongated body in the paravalvular leak path. A 6 Fr guide catheter was advanced into the left ventricle and radiocontrast was injected through the 6 Fr guide catheter using the side arm of the Tuohy-Borst adapter to achieve complete occlusion of the paravalvular leak and dilated removable Confirm proper placement of the balloon and the first elongated body. The physician then removes the 6Fr guide catheter and introducer sheath in the right femoral artery and seals the hole in the right femoral artery with a closure device, successfully occluding the paravalvular aortic leak. Over the next few months, the elongated body within the central void of the balloon helps the balloon resist deflation, compression, or compaction. A thin outer layer of gold on the balloon surface induces a complete layer of new endothelium on the blood-contacting surface of the balloon, seals the paravalvular leak pathway, and induces the formation of a capsule of tissue that holds the balloon in place.

Example 35 Treatment of Basilar Aneurysm Using a Removable Flexible Metal-Coated Polymer Balloon Catheter and a Single Elongated Body
In this treatment example, a detachable balloon catheter comprising a flexible metal-coated polymer balloon 8 mm in diameter and 5.3 mm in length, excluding the proximal and distal necks, was used as in Example 1. Placed in a basilar aneurysm as described. Then, as described in Example 1, a first elongated body of 100 cm has a distal portion in the aneurysm sac distal to the inflated removable balloon and a proximal portion inflated. positioned within the central cavity of the attached removable balloon. In this example, prior to removal of either the first elongated body or the expanded removable balloon, the physician may determine whether the expanded removable balloon diameter is too small to provide adequate therapy. , and whether the length of the first elongated body is too short. The physician removes the first elongate body from the expanded removable balloon by pulling on the second elongate body and then from the patient. The physician then uses an inflation device to apply negative pressure to the inflation port of the first catheter hub of the removable balloon catheter, resulting in deflation of the expanded removable balloon. The physician removes the removable balloon from the aneurysm by pulling on the first of the removable balloon catheters and removes the removable balloon catheter from the patient. The physician then uses the method described in Example 1 to successfully create an aneurysm with a detachable balloon catheter having a larger balloon and a second medical device having a longer first elongated body. Treat backwards.

Example 36 Treatment of the Left Atrial Appendage Using a Removable Flexible Metal-Coated Polymer Balloon Catheter and a Single Elongated Body
In this treatment example, the left atrial appendage (LAA) is treated with a detachable balloon catheter as described in Example 7. After exposing the retention mechanism and expanding the removable balloon of the removable balloon catheter, the physician determines that the expanded removable balloon extends into the right atrium. Using an inflation device, the physician applies negative pressure to the inflation port of the hub of the first catheter of the removable balloon catheter to deflate the expanded removable balloon. The physician opens the rotating valve lock in the hub of the third catheter and removes the removable balloon until the balloon is covered by the third catheter and the retention structure is deflated and covered by the third removable balloon. The tip of the third catheter is advanced forward while the first and second catheters remain fixed in place. The physician advances the detachable balloon catheter further into the LAA and successfully completes treatment of the LAA using the method described in Example 7.

Example 37 Treatment of Basilar Aneurysm Using a Removable Flexible Metal-Coated Polymer Balloon Catheter and a Single Elongated Body
i) The male tubular structure is replaced by an electrolytic or anode sensitive tubular structure, the proximal end of the anode 390 being joined to the distal end of the first catheter and the distal end of the anode 390 being detachable. ii) the inner surface of the platinum cathode ring structure is bonded to the outer surface of the central section of the first catheter; iii) the first iv) an electrically conductive wire electrically connects the anode 390 to an electrical jack on the hub of the first catheter; and v) an electrically conductive wire is electrically connected to the first catheter hub. The detachable balloon catheter (or the first is provided comprising a pleated, folded removable flexible metallized polymeric balloon and a catheter assembly including a first catheter and a second catheter .

The physician places the inflated removable balloon and first elongated body into the aneurysm, as described in Example 1, until the detachment step. A conductive cable is used to make an electrical connection between the electrolytic detachment controller and an electrical jack on the hub of the first catheter. A current of 2 mA is applied to the anode 390, corroding and dissolving the exposed stainless steel ring. Current is applied until the anode 390 is disconnected. Thereafter, as described in Example 1, continue until the remainder of the treatment is successfully completed.

Example 38 Treatment of Basilar Aneurysm Using Removable Flexible Metal-Coated Polymer Balloon Catheter and Single Elongated Body
i) the male tubular structure is replaced by a heat sensitive tubular structure, the proximal end of the heat sensitive tubular structure being joined to the distal end of the first catheter, and the heat sensitive tubular structure A pleated and folded detachable device as described in Example 1, except that the distal end of the detachable balloon is joined to the female tubular structure of the proximal neck assembly of the detachable balloon. A detachable balloon catheter (or first medical device) is provided that includes a flexible, metallized polymeric balloon and a catheter assembly that includes a first catheter and a second catheter. .

The physician places the expanded removable balloon and first elongated body within the aneurysm, as described in Example 1, until the detachment step. The first elongated body is removed from the second elongated body as described in Example 1. The second elongated body is removed from the second catheter of the removable balloon catheter and the second catheter is removed from the patient. A third device comprising a catheter having a conductive wire and a resistive wire segment at its distal end is placed over the second detachable balloon catheter until the resistive wire segment is positioned within the heat sensitive tubular structure. The lumen of the catheter is advanced. An electrically conductive cable is used to electrically connect the electrothermal detachment controller and an electrical jack on the hub of the third medical device. When a current is applied to the resistance wire, the resistance wire heats up, melting the heat sensitive tubular structure and cutting the heat sensitive tubular structure. As described in Example 1, the first catheter of the detachable balloon catheter and the third medical device are removed from the patient, followed by the remainder of the procedure being successfully completed.

Example 39 Treatment of Basilar Aneurysm Using a Detachable Flexible Metal-Coated Polymer Balloon Catheter and Two or More Elongated Bodies
A detachable balloon catheter (or first medical device) is a catheter comprising a pleated, folded detachable flexible metal-coated polymer balloon and a first catheter and a second catheter and an assembly.

The removable balloon includes a proximal neck and a distal neck. A female tubular structure is bonded to the proximal neck of a removable flexible metallized polymer balloon. A distal portion of the female tubular structure protrudes into the central void of the balloon. A telescoping catheter segment with proximal and distal marker bands is joined to the distal neck of the removable balloon. A proximal portion of the retractable catheter segment protrudes into the central void of the removable balloon. Excluding the proximal and distal neck lengths, the removable balloon has a diameter of 8 mm (measured in a plane parallel to the second axis) and a length of 5.3 mm (parallel to the first axis). measured on a smooth plane). Proximal region 110 and distal region 120 of removable balloon 10 are curvilinear. The wall of the removable balloon comprises an inner layer of PET with a single wall thickness of 10 μm made by blow molding and an outer layer of gold with a single wall thickness of 1000 Å made by sputter deposition on the outer surface of the PET base layer.

The first catheter includes a proximal end having a hub containing a port for infusing fluid and a distal end generally opposite the proximal end, the distal end of the first catheter having three It is joined to the proximal end of a male tubular structure having arms and tabs. The distal end of the male tubular structure is operably connected to a female tubular structure that is joined to the proximal neck of the removable balloon. The distal end of the first catheter further includes a fluoroscopic marker band. The first catheter hub also includes a rotating valve block configured to secure the first catheter hub to the second catheter shaft. A second catheter includes a proximal end having a hub containing a port for receiving a 0.014 inch guidewire and an open distal end. The second catheter further includes two fluoroscopic marker bands to facilitate placement and removal of the first elongated body. The second catheter is longer than the first catheter. The proximal portion of the second catheter passes through the hub of the first catheter and is secured to the hub of the first catheter by a rotating valve block. A central portion of the second catheter passes through the lumen of the first catheter. The distal portion of the second catheter is pleated and passed through the proximal neck opening, the central void, the distal neck opening, and the telescoping catheter segment of the folded detachable balloon, and detachable. It extends distally to the distal end of the distal neck telescoping catheter segment of the possible balloon. The inner surface of the first catheter and the outer surface of the second catheter are such that the fluid medium passes from the proximal end of the first catheter to the distal end of the first catheter and into the central void of the removable balloon. A first lumen is defined to allow for A lumen of the second catheter defines a second lumen.

The physician advances the needle into the right femoral artery of a patient with a terminal saccular aneurysm of the basilar artery retrogradely and advances a 0.035 inch guidewire into the artery. The needle is removed and a 6Fr introducer sheath is placed in the right femoral artery. A 6 Fr guide catheter with Tuohy-Borst adapter is inserted through the introducer sheath and advanced over the guidewire to the origin of the right vertebral artery. A standard digital subtraction angiogram is performed to confirm the size of the aneurysm. The aneurysm neck diameter measures 6 mm, the aneurysm width and depth measures 9 mm, and the aneurysm height measures 12 mm. The 0.035 inch guidewire is removed and a 2Fr catheter is advanced over the 0.014 inch guidewire until its tip is within the aneurysm sac. A 12 mm x 40 cm framing coil is placed in the aneurysm sac. Remove the 2Fr catheter. The physician removes residual air from the removable balloon catheter, forms pleats, and places the folded removable balloon in the center of the aneurysm sac and over the loops of the pre-placed framing coil. Advance it over a 0.014 inch guidewire until deployed. An inflation device filled with a mixture of 50% saline and 50% radiocontrast (by volume) is attached to the inflation port of the first catheter and the inflation device is used to mix the saline and contrast. is injected through the lumen of the first catheter into the central void of the balloon at a pressure of 2 atmospheres, resulting in full inflation of the balloon. The physician then pushes the expanded removable balloon until the proximal surface of the expanded removable balloon contacts the pre-placed loops of the framing coil at the neck of the aneurysm. Pull back by pulling on the second catheter assembly. The physician opens a valved rotation lock in the hub of the first catheter to allow movement of the second catheter and places the tip of the second catheter over the guidewire into the unfilled artery with an inflated removable balloon. Advance to the distal end of the aneurysm sac while maintaining the position of the inflated removable balloon and first catheter. The physician then selects a second medical device comprising a 100 cm long first elongated body comprising a coiled platinum wire joined to a second elongated body comprising a pusher wire. The first elongate body has a secondary diameter of 0.014 inches and includes a single 4 mm tertiary loop at the distal end, the remainder of the first elongate body having no tertiary shape when relevant. . The first elongated body is joined to the second elongated body (pusher wire) by mechanical attachment. The guidewire is removed from the lumen of the second catheter and the first elongated body is inserted into the lumen of the second catheter and advanced into the aneurysm sac under fluoroscopy. The physician advances the distal 70 cm of the first expandable body into the aneurysm sac using visual markings on the second elongated body of the second medical device for guidance. Continuous occlusion of the aneurysm neck with framing coils and dilated detachable balloons and dilated detachables by injection of radiocontrast through a 6Fr guide catheter using the side arm of the Tuohy-Borst adapter Proper placement of the correct balloon and first elongated body is confirmed. Under fluoroscopy, a telescoping catheter segment with a second catheter tip within the central void of the expanded removable balloon and coupled to the distal neck of the expanded removable balloon. withdraw until close to the proximal portion of the catheter, while the removable balloon and first catheter remain fixed and unchanged. The physician then advances the remaining 30 cm of the first expandable body into the central void of the expanded removable balloon. Injection of radiocontrast through a 6 Fr guide catheter using the side arm of the Tuohy-Borst adapter to occlude the aneurysm neck with a framing coil and an inflated removable balloon and an inflated removable balloon. Proper placement of the balloon and first elongated body is confirmed. The physician places the proximal end of the second elongated body of the second medical device into a handle provided on the second medical device, removes the first elongated body from the second elongated body, and removes the first elongated body from the patient. Remove the second elongated body. The physician then withdraws the tip of the second catheter until it is proximate the connection of the male and female tubular structures, breaking the connection between the male and female structures. The physician then uses a marker band on each catheter and a radiopaque female tubular structure bonded to the proximal neck of the removable balloon to confirm separation. The first and second catheters are withdrawn from the patient, leaving the balloon and first elongated body within the aneurysm sac. Complete occlusion of the aneurysm neck and sac by framing coils and an inflated removable balloon and dilatation by injection of radiocontrast through a 6 Fr guiding catheter using the side arm of the Tuohy-Borst adapter. Proper placement of the removable balloon and first elongated body is confirmed. The physician then removed the right femoral artery introducer sheath and sealed the hole in the right femoral artery with a closure device, successfully occluding the saccular aneurysm. Over the next few months, the elongated body within the central void of the balloon helps the balloon resist deflation, compression, or compaction. A thin outer layer of gold on the balloon surface induces a complete layer of new endothelium on the blood-contacting surface of the balloon that completely seals the aneurysm neck and also encourages the formation of a tissue capsule that holds the balloon in place. Induce. In this example, the expanded detached balloon is used to fill the core of the aneurysm after placement of one or more framing coils and one, several, or many finishing coils. ) is used instead of

(Other treatment examples)
Those skilled in the art will appreciate that the foregoing Examples 27, 28, 35, 37 and 38 can be used to treat other types of saccular aneurysms, including sidewall aneurysms and other types of bifurcation aneurysms. Will. Those skilled in the art will appreciate that the methods described in Examples 31-38 can be used to treat other blood-containing structures, biological conduits and biological spaces.
Aspects and embodiments of the disclosure are presented in the following sections

Aspects and embodiments related to methods of manufacturing the systems and devices disclosed herein:

[Aspect 1]
(1)(a)(i) a distal region, generally a proximal region opposite said distal region, an intermediate region transitioning from said distal region to said proximal region;
(ii) a wall having an outer surface and an inner surface, the inner surface defining a central void or interior volume, extending generally continuously from the proximal region through the intermediate region to the distal region;
(iii) permit passage of fluid from the first catheter into the central void or interior volume of the balloon and permit passage of a portion of the second catheter into the central void or interior volume of the balloon; an opening in the wall in the proximal region;
(iv) an opening in the wall of the distal region that allows passage of a portion of the second catheter into the central void or interior volume of the balloon;
a compressed, deflated or pleated, folded balloon configured for permanent implantation within a human patient upon expansion;
(b) a first lumen for allowing passage of fluid from the proximal end of the first catheter to the distal end of the first catheter and into the central void or interior volume of the balloon; define,
(i) a proximal end connected to a first proximal hub; and
(ii) a first catheter comprising a distal portion operably connected or joined to an opening in the wall of the proximal region of the balloon;
(c) defining an elongated body, expandable body, or second lumen configured to receive a clotting fluid;
(i) a proximal end connected to a proximal hub;
(ii) a proximal portion passing through the proximal hub of the first catheter;
(iii) an opening in the wall of the proximal region of the balloon and a distal portion passing through the central void or interior volume of the balloon and extending beyond the opening in the wall of the distal region of the balloon; and
(iv) a second catheter comprising a distal upper end having an open end;
a first medical device comprising
(2) a second catheter configured to push the first elongate body or expandable body into the lumen of the second catheter and to withdraw the first elongate body or expandable body from the lumen of the second catheter; a second medical device comprising a first elongated body or an expandable body configured for permanent implantation within a human patient joined to the elongated body of the;
including
the balloon can be expanded by passage of fluid through the first catheter and into the central void or interior volume of the balloon;
After inflation of the balloon, the second catheter can be moved forward or backward while the inflated balloon remains fixed in place;
After expansion of the balloon, all or a portion of the elongated body, expandable body, or one or more second medical devices containing the coagulating fluid is passed through the lumen of the second catheter and into the biological region adjacent to the balloon. can be placed in the target space,
After inflation of the balloon, pulling back the second catheter until the distal tip of the second catheter is positioned within the central void or interior volume of the balloon while the first catheter and balloon remain fixed in place. and passing all or a portion of one or more second medical devices comprising an elongated body, an expandable body, a coagulating fluid or other balloon support material through the second lumen of the second catheter; can be positioned within the central void or interior volume of the balloon,
After expansion of the balloon and placement of all or a portion of one or more second medical devices comprising an elongated body, expandable body, coagulating fluid or other balloon supporting material, the first catheter is separated from the expanded balloon. and removing the first and second catheters from the patient while leaving all or a portion of the balloon and one or more of the elongated bodies, the expandable body, the coagulating fluid or other balloon supporting material within the patient. can be
The first elongated or expandable body is passed in an elongated, constrained, compressed, or deflated configuration through the lumen of the second catheter of the first medical device and into the human patient. is configured to pass into
at least a portion of the first elongated or expandable body is configured for implantation within the interior volume of the balloon of the first medical device;
the first elongate body or expandable body is separable from the second elongate body;
One or more catheters for treating a human patient, characterized in that the second elongate body can be removed from the lumen of the second catheter while leaving the first elongate body in place within the patient. Systems containing medical devices.
[Aspect 2]
Aspect 1. The system of aspect 1, wherein the balloon of the first medical device comprises a polymer.
[Aspect 3]
3. The system of aspect 2, wherein the polymer comprises polyethylene terephthalate (PET), polyamide (nylon), or polyether block amide (Pebax).
[Aspect 4]
4. Any one of aspects 1-3, wherein the proximal portion of the balloon comprises a proximal neck projecting from the balloon and a radiopaque tubular segment visible under fluoroscopy is joined to the proximal neck of the balloon. The system described in paragraph.
[Aspect 5]
4. Any one of aspects 1-3, wherein the distal portion of the balloon comprises a distal neck projecting from the balloon, and a radiopaque tubular segment visible under fluoroscopy is joined to the distal neck of the balloon. The system described in paragraph.
[Aspect 6]
A proximal portion of the balloon includes a proximal neck projecting from the balloon, a radiopaque tubular segment joined to the proximal neck of the balloon, and a distal portion of the balloon projecting from the balloon. 4. The system of any one of aspects 1-3, comprising a distal neck, wherein a radiopaque tubular segment is joined to the distal neck of the balloon.
[Aspect 7]
7. Any of aspects 1-6, wherein the first catheter or first medical device includes a radiopaque marker that is clearly visible under fluoroscopy at or near the distal end of the first catheter. 1. The system according to claim 1.
[Aspect 8]
After expansion of the balloon of the first medical device, the second catheter of the first medical device can be moved forward or backward while the first catheter of the first medical device remains fixed in place. A system according to aspect 1.
[Aspect 9]
the second catheter of the first medical device comprises two radiopaque markers visible under fluoroscopy at or near the distal end of the catheter; Aspect 1. Aids in the passage of the elongate body or assists in removal of the first elongate body or expandable body passing through the lumen of the expandable body second catheter and through the lumen of the second catheter. system.

[Aspect 10]
10. The medical device of aspect 9, wherein the first marker band is 0.3-1.5 mm from the distal end of the second catheter of the first medical device.
[Aspect 11]
The first marker band is 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 10. The medical device of aspect 9, wherein the medical device is 1.1, 1.2, 1.3, 1.4, or 1.5 mm proximal.
[Aspect 12]
12. The medical device of any one of aspects 9-11, wherein the second marker band is 2.0-4.0 mm proximal to the distal end of the second catheter of the first medical device.
[Aspect 13]
The system of any one of aspects 4-7 and 9-12, wherein the radiopaque marker comprises platinum, iridium, gold, tungsten, or combinations thereof.
[Aspect 14]
A system according to aspect 1, wherein the first elongated or expandable body of the second medical device comprises a coiled wire.
[Aspect 15]
15. The system of aspect 14, wherein the primary diameter of the coiled wire is between 0.00175 and 0.003 inches.
[Aspect 16]
16. The system of aspect 14 or 15, wherein the first elongated or expandable body of the second medical device is a coiled wire and the secondary diameter of the coiled wire is 0.010 to 0.050 inches.
[Aspect 17]
The secondary diameter of the coiled wire of the first elongate body or expandable body is 0.010, 0.011, 0.012, 0.013, 0.014, 0.015, 0.016, 0. 017, 0.018, 0.019, 0.020, 0.021, 0.023, 0.024, 0.025, 0.026, 0.027, 0.028, 0.029, 0.030, 0.031, 0.032, 0.033, 0.034, 0.035, 0.036 or 0.037, 0.038, 0.039, 0.040, 0.041, 0.042, 0 16. The system of any one of aspects 1-15, wherein the system is 0.043, 0.044, 0.045, 0.046, 0.047, 0.048, 0.049 or 0.050 inches.
[Aspect 18]
18. The system of any one of aspects 14-17, wherein the first elongate body or expandable body has a tertiary structure without preformed loops or shapes.
[Aspect 19]
18. The system of any one of aspects 14-17, wherein the first elongate body or expandable body is configured to form a straight or unformed tertiary shape when relaxed.
[Aspect 20]
18. The medical device of any one of aspects 14-17, wherein the coiled wire is a straight vascular coil.
[Aspect 21]
6. The system of aspect 5, wherein at least a portion of the first elongate body or expandable body has a helical, spherical, or complex tertiary structure.
[Aspect 22]
The first elongate body or expandable body is a coiled wire, and at least a portion of the first elongate body or expandable body forms a coiled, helical, or complex tertiary shape when relaxed. 18. The system of any one of aspects 14-17, wherein the system is configured to:
[Aspect 23]
18. The medical device of any one of aspects 14-17, wherein the coiled wire is a vascular coil.
[Aspect 24]
A distal portion of the first elongate body or expandable body includes one loop of tertiary structure, and upon relaxation, the remainder of the first elongate body or expandable body assumes a preformed loop or shape. 24. The system of any one of aspects 20-23, comprising no tertiary structure.
[Aspect 25]
The distal portion of the first elongated body or expandable body comprises one loop of tertiary structure and the remainder of the first elongated body or expandable body is straight or unshaped tertiary shape if 24. The system of any one of aspects 20-23, comprising a tertiary structure configured to form a
[Aspect 26]
A distal portion of the first elongated body or expandable body has a preformed loop or shape when relaxed comprising two tertiary structural loops and a remaining portion of the first elongated body or expandable body. 24. The system of any one of aspects 20-23, comprising a tertiary structure having no
[Aspect 27]
A distal portion of the first elongate body or expandable body forms a straight or unformed tertiary shape including two tertiary structure loops and a remaining portion of the first elongate body or expandable body. 24. The system of any one of aspects 20-23, comprising a tertiary structure configured to.
[Aspect 28]
When the distal portion of the first elongated body or expandable body comprises three loops of tertiary structure the remainder of the relaxed first elongated body or expandable body has preformed loops or shapes. 24. The system of any one of aspects 20-23, wherein the system comprises no tertiary structure.
[Aspect 29]
The distal portion of the first elongated body or expandable body includes three loops of tertiary structure and the remaining portion of the first elongated body or expandable body is straight or unshaped tertiary shape if 24. The system of any one of aspects 20-23, comprising a tertiary structure configured to form a
[Aspect 30]
24. Any one of aspects 20-23, wherein the distal portion of the relaxed first elongate body or expandable body comprises preformed loops or four or more loops of unshaped tertiary structure. system.
[Aspect 31]
A distal portion of the first elongate body or expandable body includes four tertiary structure loops and a remaining portion of the first elongate body or expandable body to form a straight or unshaped tertiary shape. 24. The system of any one of aspects 20-23, comprising a tertiary structure configured to.
[Aspect 32]
31. The system of any one of aspects 21-30, wherein the looped, coiled or formed portion of the first elongate body or expandable body has a tertiary diameter of 2-100 mm.
[Aspect 33]
The tertiary diameter of the looped, coiled or formed portion of the first elongate body or expandable body is 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 , 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38 , 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63 , 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88 , 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, or 100 mm.
[Aspect 34]
33. The system of any one of aspects 14-32, wherein the first elongate body or expandable body comprises platinum, iridium, nickel, tungsten, or combinations thereof.
[Aspect 35]
A system according to aspect 1, wherein the first elongate body or expandable body of the second medical device is a wire.
[Aspect 36]
35. The system of aspect 34, wherein the wire diameter is 0.005 to 0.050 inches.
[Aspect 37]
The wire diameters are 0.017, 0.018, 0.019, 0.020, 0.021, 0.023, 0.024, 0.025, 0.026, 0.027, 0.028, 0.029, 0.030 , 0.031, 0.032, 0.033, 0.034, 0.035, 0.036, or 0.037, 0.038, 0.039, 0.040, 0.041, 0.042, 35. The system of aspect 34, which is 0.043, 0.044, 0.045, 0.046, 0.047, 0.048, 0.049, or 0.050 inches.
[Aspect 38]
37. The system of aspect 35 or 36, wherein the diameter of the wire is the primary diameter.
[Aspect 39]
38. The system of any one of aspects 34-37, wherein the wire has no secondary diameter.
[Aspect 40]
38. The system of any one of aspects 34-37, wherein the first elongate body or expandable body has a tertiary structure without preformed loops or shapes.
[Aspect 41]
37. The system of any one of aspects 34-36, wherein the first elongate body or expandable body is configured to form a straight or unformed tertiary shape when relaxed.
[Aspect 42]
37. The medical device of any one of aspects 34-36, wherein the coiled wire is a straight vascular coil.
[Aspect 43]
37. The system of any one of aspects 34-36, wherein at least a portion of the first elongate body or expandable body has a helical, spherical, or complex tertiary structure.
[Aspect 44]
When relaxed, the distal portion of the first elongated body or expandable body includes one loop of tertiary structure and the remainder of the first elongated body or expandable body comprises preformed loops or 37. The system of any one of aspects 34-36, comprising a shapeless tertiary structure.
[Aspect 45]
When relaxed, the distal portion of the first elongate body or expandable body includes one loop of tertiary structure and the remaining portion of the first elongate body or expandable body is straight or unshaped. 37. The system of any one of aspects 34-36, comprising a tertiary structure configured to form a tertiary shape.
[Aspect 46]
When relaxed, the distal portion of the first elongated body or expandable body includes two loops of tertiary structure and the remainder of the first elongated body or expandable body comprises preformed loops or 37. The system of any one of aspects 34-36, comprising a shapeless tertiary structure.
[Aspect 47]
When relaxed, the distal portion of the first elongate body or expandable body includes two loops of tertiary structure and the remaining portion of the first elongate body or expandable body is straight or unshaped. 37. The system of any one of aspects 34-36, comprising a tertiary structure configured to form a tertiary shape.
[Aspect 48]
When relaxed, the distal portion of the first elongated body or expandable body includes three loops of tertiary structure and the remainder of the first elongated body or expandable body comprises preformed loops or 37. The system of any one of aspects 34-36, comprising a shapeless tertiary structure.
[Aspect 49]
When relaxed, the distal portion of the first elongate body or expandable body includes three loops of tertiary structure and the remainder of the first elongate body or expandable body is straight or unshaped. 37. The system of any one of aspects 34-36, comprising a tertiary structure configured to form a tertiary shape.
[Aspect 50]
37. The system of any one of aspects 34-36, wherein, when relaxed, the distal portion of the first elongate body or expandable body comprises four or more loops of tertiary structure.
[Aspect 51]
50. The system of any one of aspects 34-49, wherein the looped, coiled or formed portion of the first elongate body or expandable body has a tertiary diameter of 2-100 mm.
[Aspect 52]
The tertiary diameter of the looped, coiled or formed portion of the first elongate body or expandable body is 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 , 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38 , 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63 , 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88 , 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, or 100 mm.
[Aspect 53]
52. The system of any one of aspects 34-51, wherein the wire comprises nitinol.
[Aspect 54]
53. The system of aspect 52, wherein the Nitinol wire is plated or coated with platinum or gold.
[Aspect 55]
54. The system of aspect 52 or 53, wherein the nitinol wire further comprises one or more radiopaque markers that are clearly visible under fluoroscopy.
[Aspect 56]
55. The system of aspect 54, wherein the radiopaque marker comprises platinum, iridium, gold, tungsten, or combinations thereof.
[Aspect 57]
56. The system of aspect 54 or 55, wherein the radiopaque marker is in the form of a ring or band around the portion of the wire.
[Aspect 58]
The second medical device further includes a catheter, and the first elongated body or expandable body of the second medical device is connected by the catheter of the second medical device to the second catheter of the first medical device. 57. The system of any one of aspects 34-56, configured to be delivered through a lumen.
[Aspect 59]
58. The system of aspect 57, wherein the distal portion of the catheter includes radiopaque markers that are clearly visible under fluoroscopy.
[Aspect 60]
59. The system of aspect 58, wherein the radiopaque marker comprises platinum, iridium, gold, tungsten, or combinations thereof.
[Aspect 61]
The system of aspect 1, wherein the first elongated or expandable body of the second medical device comprises a wire assembly, a coiled wire assembly, a braided wire assembly, a woven wire assembly, or other expandable body.
[Aspect 62]
61. The system of aspect 60, wherein the first elongated or expandable body of the second medical device is self-expanding.
[Aspect 63]
A wire assembly, coiled wire assembly, braided wire assembly, or textile assembly is the general shape of the expanded balloon of the first medical device when not in a compressed, deflated, constrained or elongated configuration. 62. The system of aspects 60 or 61, wherein the system is configured to form and size.
[Aspect 64]
Wire assemblies, coiled wire assemblies, braided wire assemblies, or woven assemblies are configured to form a generally cylindrical shape when not in a compressed, deflated, constrained or elongated configuration. 63. The system of any one of aspects 60-62.
[Aspect 65]
Wire assemblies, coiled wire assemblies, braided wire assemblies, or woven assemblies are configured to form a generally spherical shape when not in a compressed, deflated, constrained or elongated configuration. 63. The system of any one of aspects 60-62.
[Aspect 66]
65. The system of any one of aspects 60-64, wherein the first elongate body or expandable body of the second medical device comprises nitinol.
[Aspect 67]
66. The system of aspect 65, wherein the nitinol wire is plated or coated with platinum or gold.
[Aspect 68]
67. The system of aspect 65 or 66, wherein the nitinol wire further comprises one or more radiopaque markers that are clearly visible under fluoroscopy.
[Aspect 69]
68. The system of aspect 67, wherein the radiopaque marker comprises platinum, iridium, gold, tungsten, or combinations thereof.
[Aspect 70]
A system according to aspect 1, wherein the first elongated or expandable body of the second medical device comprises polymeric strands.
[Aspect 71]
70. The system of aspect 69, wherein the polymer strands are plated or coated with platinum or gold.
[Aspect 72]
71. The system of aspect 69 or 70, wherein the polymer strand further comprises one or more radiopaque markers that are clearly visible under fluoroscopy.
[Aspect 73]
72. The system of aspect 71, wherein the radiopaque marker comprises platinum, iridium, gold, tungsten, or combinations thereof.
[Aspect 74]
73. The system of aspect 71 or 72, wherein the radiopaque marker is in the form of a ring or band around a portion of the polymer strand.
[Aspect 75]
74. The system of any one of aspects 1-73, wherein the first elongate or expandable body is 10-400 cm long.
[Aspect 76]
74. The system of any one of aspects 1-73, wherein the first elongate or expandable body is 10-70 cm long.
[Aspect 77]
74. The system of any one of aspects 1-73, wherein the first elongate or expandable body is 70-400 cm long.
[Aspect 78]
The first elongated or expandable body has a 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 cm in length, Embodiment 1 74. The system of any one of Claims 1-73.
[Aspect 79]
78. The system of any one of aspects 1-77, wherein the first elongate body or expandable body comprises a lubricious layer or coating.
[Aspect 80]
79. The system of aspect 78, wherein the lubricating layer or coating is hydrophilic.
[Aspect 81]
80. The system of aspect 78 or 79, wherein the coating is a Serene® coating available from SurModics or an Assist® coating available from Biolinteractions.
[Aspect 82]
80. The system of aspect 78 or 79, wherein the lubricious layer is PTFE, polyimide, PTFE and polyimide composites.
[Aspect 83]
82. The system of any one of aspects 1-81, wherein the second elongated body comprises a lubricious layer or coating.
[Aspect 84]
83. The system of aspect 82, wherein the lubricating layer or coating is hydrophilic.
[Aspect 85]
84. The system of aspect 82 or 83, wherein the coating is a Serene® coating available from SurModics or an Assist® coating available from Biolinteractions.
[Aspect 86]
84. The system of aspects 82 or 83, wherein the lubricious layer is PTFE, polyimide, PTFE and polyimide composites.
[Aspect 87]
The second elongated body of the second medical device determines to the user the length of the first elongated body or expandable body pushed distally against the distal tip of the second catheter 86. The system of any one of aspects 1-85, comprising visual or tactile markings that allow
[Aspect 88]
The first elongated body or expandable body of the second medical device expands the first elongated body into an artery, vein, left atrial appendage, aneurysm, blood-containing space, biological conduit, or the first medical device. 87. The system of any one of aspects 1-86, wherein the system is coupled to the second elongate body of the second medical device by a bond or bond that can be separated after placement within the central void or interior volume of the balloon. .
[Aspect 89]
The first elongate body or expandable body of the second medical device is joined to the second elongate body of the second medical device and the first elongate body or expandable body of the second medical device is After expulsion from the distal end of the second catheter of the first medical device,

The second elongated body of the second medical device can be separated from the first elongated or expandable body of the second medical device, leaving the first elongated or expandable body within the patient. 87. The system of any one of aspects 1-86, wherein the second elongate body can be removed from the patient while the second elongate body is removed.
[Aspect 90]
89. The system of aspect 87 or 88, wherein the first elongate body or expandable body of the second medical device and the second elongate body of the second medical device are configured to separate by mechanical means. .
[Aspect 91]
89. According to aspect 87 or 88, the first elongate body or expandable body of the second medical device and the second elongate body of the second medical device are configured to separate by electrolysis or corrosion. system.
[Aspect 92]
91. The system of any one of aspects 87, 88, and 90, wherein the separation region between the first elongated body or expandable body and the second elongated body is sensitive to electrolysis or corrosion.
[Aspect 93]
92. The system of aspect 90 or 91, wherein the segment sensitive to electrolysis or corrosion comprises stainless steel.
[Aspect 94]
the second elongated body of the second medical device is configured to allow passage of electrical current from a proximal portion of the second elongated body to an area sensitive to electrolysis or corrosion; 93. The system of any one of aspects 90-92.
[Aspect 95]
94. The system of aspect 93, wherein at least a portion of the second elongated body of the second medical device is configured to allow passage of direct current.
[Aspect 96]
95. The system of any one of aspects 90-94, wherein at least a portion of the second elongated body of the second medical device is coated with a material that insulates it from electrical conduction.
[Aspect 97]
96. Any one of aspects 90-95, wherein at least a portion of the segment configured to be electrolytically or corrosion sensitive or to be dissolved by electrolysis is not covered with a material that insulates it from electrical conduction The system described in paragraph.
[Aspect 98]
89. The system of aspect 87 or 88, wherein the first elongated body or expandable body of the second medical device and the second elongated body of the second medical device are configured to separate by electrothermal methods.
[Aspect 99]
98. The system of aspect 97, wherein the separation occurs in a region between the first elongate body or expandable body and the second elongate body that can be melted by heating.
[Aspect 100]
The second medical device is heat-resistant from a proximal portion of the second elongate body at or near a region between the first elongate body or expandable body and the second elongate body that can be melted by heating. 99. A system according to aspect 97 or 98, configured to allow passage of electrical current to the element.
[Aspect 101]
99. The system of any one of aspects 97-99, wherein at least a portion of the second elongated body of the second medical device is covered with a material that insulates it from electrical conduction.
[Aspect 102]
The first elongated body or expandable body of the second medical device and the second elongated body of the second medical device are unjoined, and the second elongated body of the second medical device 87. The method of any one of aspects 1-86, configured to push the first elongate or expandable body of the second medical device through the lumen of the second catheter of the one medical device. system.
[Aspect 103]
such that the second elongate body of the second medical device ejects the first elongate body or expandable body of the second medical device from the distal end of the lumen of the second catheter of the first medical device 102. The system of aspect 101, wherein:
[Aspect 104]
the second elongated body of the second medical device after expulsion of the first elongated body or expandable body of the second medical device from the distal end of the lumen of the second catheter of the first medical device; 103. The system of aspect 101 or 102, wherein the system is removable from the lumen of the second catheter of the first medical device.
[Aspect 105]
A first elongate body or expandable body configured to join the end of the carrier holding the distal end of the first elongate body or expandable body to the proximal hub of the second catheter 104. The system of any one of aspects 1-103, comprising at least a portion of the carrier and the second elongate body.
[Aspect 106]
105. The system of aspect 104, wherein the carrier is configured in a coil shape.
[Aspect 107]
106. Any of aspects 1-105, wherein a portion of the first elongate body or expandable body of the second medical device is configured to contact an inner surface of the expanded balloon of the first medical device 2. The system of claim 1.
[Aspect 108]
The maximum overall or tertiary diameter of the first elongated or expandable body of the second medical device is in the range of 5% less to 20% greater than the maximum diameter of the expanded balloon of the first medical device. 107. The system of any one of aspects 1-106.
[Aspect 109]
The maximum overall or tertiary diameter of the first elongated or expandable body of the second medical device is 1, 2, 3, 4, 5, 1, 2, 3, 4, 5, 108. The system of any one of aspects 1-107, wherein the system is 6, 7, 8, 9, or 10 mm larger.
[Aspect 110]
109. Embodiment according to any one of aspects 1-108, wherein the volume of the one or more first elongated or expandable bodies of the second medical device fills 5-75% of the volume of the central void of the expanded balloon. system.
[Aspect 111]
The volume of the one or more first elongated or expandable bodies of the second medical device is 5, 6, 7, 8, 9, 10, 11, 12, 13 the volume of the central void of the expanded balloon , 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38 , 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63 , 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, or 75%.
[Aspect 112]
the first elongated body or the expandable body is flexible and the second elongated body is flexible, or the first elongated body and the second elongated body are flexible; 111. The system of any one of aspects 1-110.
[Aspect 113]
advancing a first medical device over the guidewire into an artery, vein, left atrial appendage, other blood-containing structure, biological conduit, or biological space;
inflating the balloon of the first medical device;
removing the guidewire from the lumen of the second catheter of the first medical device;
The tip of the second catheter of the first medical device is positioned within the central void or inner lumen of the expanded balloon of the first medical device while the expanded balloon of the first medical device remains fixed in place. pulling back the second catheter of the first medical device until the
passing the first elongated or expandable body of the second medical device through the lumen of the second catheter of the first medical device and through the central cavity or inner lumen of the expanded balloon of the first medical device; placed within the
separating the first elongate body or expandable body of the second medical device from the second elongate body of the second medical device;
separating the balloon of the first medical device from the first catheter of the first medical device;
Any of aspects 1-111 in a human patient, wherein the first catheter of the first medical device, the second catheter of the first medical device, and the second elongated body of the second medical device are removed from the patient A method of using the system of claim 1.
[Aspect 114]
advancing a first medical device over the guidewire into an artery, vein, left atrial appendage, other blood-containing structure, biological conduit, or biological space;
inflating the balloon of the first medical device;
removing the guidewire from the lumen of the second catheter of the first medical device;
passing a distal portion of a first elongated or expandable body of a second medical device through the lumen of a second catheter of the first medical device and an artery distal to the inflated balloon; placed within the lumen of a vein, other blood-containing structure, biological conduit, or biological space;
The tip of the second catheter of the first medical device is positioned within the central void or inner lumen of the expanded balloon of the first medical device while the expanded balloon of the first medical device remains fixed in place. pulling back the second catheter of the first medical device until the
The remaining portion of the first elongated or expandable body of the second medical device is passed through the lumen of the second catheter of the first medical device and centrally of the expanded balloon of the first medical device. placed in the air gap or internal lumen,
separating the first elongate body or expandable body of the second medical device from the second elongate body of the second medical device;
separating the balloon of the first medical device from the first catheter of the first medical device;
Arteries, veins, other blood-containing structures, biological conduits of a human patient from which the first catheter and second catheter of the first medical device and the second elongated body of the second medical device are removed from the patient. , or a method of using the system of any one of aspects 1-111 to treat a biological space.
[Aspect 115]
advancing a first medical device over the guidewire into the aneurysm sac;
expanding the balloon of the first medical device within the aneurysm sac;
retracting the expanded balloon of the first medical device until a portion of the outer surface of the expanded balloon contacts a portion of the neck of the aneurysm;
removing the guidewire from the lumen of the second catheter of the first medical device;
optionally, while holding the expanded balloon of the first medical device in place, advancing a second catheter of the first medical device into the aneurysm sac distal to the expanded balloon;
A distal portion of a first elongated body or expandable body of a second medical device is passed through the lumen of a second catheter of the first medical device and an aneurysm distal to the inflated balloon. placed in the sac,
The tip of the second catheter of the first medical device is positioned within the central void or inner lumen of the expanded balloon of the first medical device while the expanded balloon of the first medical device remains fixed in place. pulling back the second catheter of the first medical device until the
The remaining portion of the first elongated or expandable body of the second medical device is passed through the lumen of the second catheter of the first medical device and centrally of the expanded balloon of the first medical device. placed within the void or internal lumen,
separating the first elongate body or expandable body of the second medical device from the second elongate body of the second medical device;
separating the balloon of the first medical device from the first catheter of the first medical device;
112. The system of any one of aspects 1-111 in a human patient, wherein the first catheter and the second catheter of the first medical device and the second elongated body of the second medical device are removed from the patient. how to use.
[Aspect 116]
A distal portion of the first elongated body or expandable body of the second medical device was positioned within the aneurysm or left atrial appendage and a proximal portion of the second elongated body of the second medical device was expanded. The volume of the portion of the first elongated body or expandable body within the aneurysm or left atrial appendage, when positioned within the central void of the removable balloon, is the volume of the remaining unfilled aneurysm or left atrial appendage. filling 5-75% of the volume of the portion, and the volume of the portion of the first elongated body or expandable body within the central void of the expanded balloon is 5-75% of the volume of the central void of the expanded balloon; 115. Use of the system according to aspect 114 with a 75% fill.
[Aspect 117]
5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21 of an aneurysm or left atrial appendage volume not filled by an inflated balloon, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 116. Use of the system according to aspect 115, wherein 72, 73, 74, or 75% is filled by the first elongate body or expandable body.
[Aspect 118]
5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25 of the central void volume of the expanded balloon , 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50 , 51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74, or 116. Use of the system according to aspect 115, wherein the system is 75% filled.

Aspects and embodiments relating to the elongate body, removal of the elongate body and separate dilatation balloon as disclosed herein:
[Aspect 1]
The elongated body is a coiled wire, and at least a portion of the first elongated body or the expandable body is configured to form a coiled, helical, or complex tertiary shape when relaxed. A medical device that includes a body.
[Aspect 2]
The distal portion of the elongated body includes one loop of tertiary structure, the central portion of the elongated body includes preformed loops or tertiary structures that have no shape when relaxed, and the proximal portion of the elongated body includes The medical device of aspect 1, comprising one loop of tertiary structure.
[Aspect 3]
The distal portion of the elongated body includes two loops of tertiary structure, the central portion of the elongated body includes preformed loops or tertiary structures that have no shape when relaxed, and the proximal portion of the elongated body includes: The medical device of aspect 1, comprising two loops of tertiary structure.
[Aspect 4]
The distal portion of the elongated body includes three loops of tertiary structure, the central portion of the elongated body includes preformed loops or tertiary structures that have no shape when relaxed, and the proximal portion of the elongated body includes The medical device of aspect 1, comprising three loops of tertiary structure.
[Aspect 5]
A distal portion of the elongated body includes one loop of tertiary structure, a central portion of the elongated body includes a tertiary structure configured to form a straight or unshaped tertiary shape when relaxed, and a A medical device according to aspect 1, wherein the proximal portion of comprises one loop of tertiary structure.
[Aspect 6]
A distal portion of the elongated body includes two loops of tertiary structure, a central portion of the elongated body includes a tertiary structure configured to form a straight or unshaped tertiary shape when relaxed, and an elongated body. A medical device according to aspect 1, wherein the proximal portion of comprises two loops of tertiary structure.
[Aspect 7]
A distal portion of the elongated body includes three loops of tertiary structure, a central portion of the elongated body includes a tertiary structure configured to form a straight or unshaped tertiary shape when relaxed, and an elongated body. A medical device according to aspect 1, wherein the proximal portion of comprises three loops of tertiary structure.
[Aspect 8]
2. The medical device of aspect 1, wherein the distal portion of the elongate body comprises a tertiary structure having no pre-formed loops or shapes when relaxed, and the proximal portion of the elongate body comprises one loop of the tertiary structure.
[Aspect 9]
2. The medical device of aspect 1, wherein the distal portion of the elongated body comprises a tertiary structure having no pre-formed loops or shape when relaxed, and the proximal portion of the elongated body comprises two loops of the tertiary structure.
[Aspect 10]
2. The medical device of aspect 1, wherein the distal portion of the elongated body comprises a tertiary structure having no pre-formed loops or shape when relaxed, and the proximal portion of the elongated body comprises three loops of the tertiary structure.
[Aspect 11]
A distal portion of the elongated body includes a tertiary structure configured to form a straight or unshaped tertiary shape when relaxed, and a proximal portion of the elongated body includes one loop of the tertiary structure. 1. The medical device according to claim 1.
[Aspect 12]
A distal portion of the elongated body includes a tertiary structure configured to form a straight or unshaped tertiary shape when relaxed, and a proximal portion of the elongated body includes two loops of the tertiary structure. 1. The medical device according to claim 1.
[Aspect 13]
A distal portion of the elongated body includes a tertiary structure configured to form a straight or unshaped tertiary shape when relaxed, and a proximal portion of the elongated body includes three loops of the tertiary structure. 1. The medical device according to claim 1.

Aspects and embodiments relating to kits incorporating medical devices as disclosed herein:
[Aspect 1]
(1)(a)(i) a distal region, generally a proximal region opposite said distal region, an intermediate region transitioning from said distal region to said proximal region, a proximal region and a distal region; a first axis extending proximally-distally between and a second axis perpendicular to the first axis;
(ii) a wall having an outer surface and an inner surface, the inner surface defining a central void or interior volume, extending generally continuously from the proximal region through the intermediate region to the distal region;
(iii) permit passage of fluid from the first catheter into the central void or interior volume of the balloon and permit passage of a portion of the second catheter into the central void or interior volume of the balloon; an opening in the wall in the proximal region;
(iv) an opening in the wall of the distal region that allows passage of a portion of the second catheter into the central void or interior volume of the balloon;
A compressed, deflated or pleated, folded balloon configured for permanent implantation within a human patient, comprising:
(b) a first lumen for allowing passage of fluid from the proximal end of the first catheter to the distal end of the first catheter and into the central void or interior volume of the balloon; define,
(i) a proximal end connected to a first proximal hub; and
(ii) a first catheter comprising a distal portion operably connected or joined to an opening in the wall of the proximal region of the balloon;
(c) defining an elongated body, expandable body, or second lumen configured to receive a clotting fluid;
(i) a proximal end connected to a proximal hub;
(ii) a portion passing through the proximal hub of the first catheter;
(iii) a distal portion passing through the central void or interior volume of the balloon and exiting the central void or interior volume of the balloon through an opening in the wall of the distal region of the balloon;
(iv) a second catheter comprising an open distal end;
and (2) (a) in a compressed, deflated, compressed or elongated form through a second catheter of the first medical device. and (b) one or more second medical devices comprising a delivery system for the one or more elongate or expandable bodies. ;
including
the balloon can be expanded by passage of fluid through the first catheter and into the central void of the balloon;
After inflation of the balloon, the second catheter can be moved forward or backward while the inflated balloon remains fixed in place;
one or more of an elongated body, an expandable body, or a coagulating fluid can be disposed through the lumen of a second catheter into the biological space adjacent the balloon after expansion of the balloon;
After expansion of the balloon, the distal end of a second catheter is positioned within the central void of the expanded balloon and one or more elongated bodies, expandable bodies, or coagulation fluids are introduced into said lumen of the second catheter. the second catheter can be pulled back until it can pass through and into the central void of the balloon;
After expansion of the balloon and placement of the elongated body, expandable body, or coagulation fluid, the first catheter can be separated from the expanded balloon, and the balloon and one or more elongated bodies, expandable bodies, or coagulation fluids are removed. A kit comprising medical devices for treating a human patient, characterized in that the first and second catheters can be removed from the patient while fluid remains in the patient.
[Aspect 2]
The kit of aspect 1, wherein the wall of the balloon comprises a monolayer of polymer.
[Aspect 3]
3. The kit of aspect 1 or 2, wherein the wall of the balloon comprises a single layer of polyethylene terephthalate (PET), polyamide (nylon), or polyether block amide (Pebax).
[Aspect 4]
4. The kit of aspect 2 or 3, wherein the balloon comprises a continuous layer of polymer.
[Aspect 5]
4. The kit of aspects 2 or 3, wherein the balloon comprises a discontinuous layer of polymer.
[Aspect 6]
A kit according to any one of aspects 2-5, wherein the balloon has a wall thickness of 5-300 μm.
[Aspect 7]
The kit of any one of aspects 2-5, wherein the balloon has a wall thickness of 0.0002 to 0.012 inches.
[Aspect 8]
The kit of any one of aspects 1-7, comprising a balloon having a proximal neck and a distal neck.
[Aspect 9]
The kit of aspect 1, wherein at least a portion of the wall of the balloon comprises two or more polymeric layers.
[Aspect 10]
10. The kit of aspect 9, wherein the inner layer of the balloon comprises polyethylene terephthalate, polyamide, or polyether block amide.
[Aspect 11]
11. The kit of aspect 10, wherein the inner layer of the balloon has a wall thickness of 5-300 μm.
[Aspect 12]
12. The kit of aspects 10 or 11, wherein the layer of polyethylene terephthalate, polyamide, or polyether block amide comprises a continuous layer.
[Aspect 13]
12. The kit of aspect 10 or 11, wherein the layer of polyethylene terephthalate, polyamide, or polyether block amide comprises a discontinuous layer.
[Aspect 14]
14. The kit of any one of aspects 9-13, comprising one or more outer layers or coatings comprising polyurethane, silicone, or poly(p-xylylene) (Parylene).
[Aspect 15]
15. The kit of aspect 14, wherein the outer layer or coating of the balloon has a wall thickness of 0.1-100 μm.
[Aspect 16]
16. The kit of aspects 14 or 15, wherein the polyurethane, silicone, or poly(p-xylylene) layer comprises a continuous layer.
[Aspect 17]
16. The kit of aspects 14 or 15, wherein the polyurethane, silicone, or poly(p-xylylene) layer comprises a discontinuous layer.
[Aspect 18]
18. The kit of any one of aspects 2-17, comprising one or more layers or coatings comprising metal having a thickness of 0.001-1 μm.
[Aspect 19]
19. The kit of aspect 18, wherein the metal comprises gold or an alloy thereof.
[Aspect 20]
19. The kit of aspect 18, wherein the metal comprises titanium or alloys thereof.
[Aspect 21]
19. The kit of aspect 18, wherein the metal comprises gold, titanium or alloys thereof or combinations thereof.
[Aspect 22]
22. The kit of any one of aspects 18-21, wherein the metal layer or coating comprises an outer layer.
[Aspect 23]
23. The kit of any one of aspects 2-22, wherein the overall wall thickness of the balloon is 5-400 μm.
[Aspect 24]
The total balloon wall thickness is 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 23. The kit of any one of aspects 2-22, which is 100, 200, 300, or 400 μm.
[Aspect 25]
23. The kit of any one of aspects 2-22, wherein the balloon has an overall wall thickness of 0.0002 to 0.016 inches.
[Aspect 26]
The kit of aspect 1, wherein the wall of the balloon comprises a single layer of metal.
[Aspect 27]
27. The kit of aspect 26, wherein the balloon comprises a continuous layer of metal.
[Aspect 28]
27. The kit of aspect 26, wherein the balloon comprises a discontinuous layer of metal.
[Aspect 29]
29. The kit of any one of aspects 26-28, wherein the wall of the balloon comprises gold, or an alloy thereof.
[Aspect 30]
29. The kit of any one of aspects 26-28, wherein the wall of the balloon comprises platinum, or an alloy thereof.
[Aspect 31]
31. The kit of any one of aspects 26-30, wherein the balloon has a wall thickness of 5-300 μm.
[Aspect 32]
The kit of any one of aspects 26-30, wherein the balloon has a wall thickness of 0.0002-0.012 inches.
[Aspect 33]
33. Any one of aspects 26-32, comprising one or more outer layers or coatings, one or more inner layers or coatings, or both one or more outer layers or coatings and one or more inner layers or coatings Kit as described.
[Aspect 34]
34. The kit of aspect 33, wherein the outer layer or coating and the inner layer or coating comprise one or more polymers.
[Aspect 35]
35. The kit of aspect 33 or 34, wherein the inner layer or coating and the outer layer or coating comprise a material that renders the metal layer non-conductive to the inner or outer surface of the balloon.
[Aspect 36]
36. A kit according to aspect 35, wherein the one or more polymers comprise polyurethane, silicone, or poly(p-xylylene).
[Aspect 37]
37. A kit according to aspect 35 or 36, wherein each outer layer or coating of the balloon has a wall thickness of 0.1-100 μm.
[Aspect 38]
38. The kit of any one of aspects 34-37, wherein at least one of the inner layer or coating or the outer layer or coating comprises a continuous layer.
[Aspect 39]
38. The kit of any one of aspects 34-37, wherein at least one of the inner layer or coating or the outer layer or coating comprises a discontinuous layer.
[Aspect 40]
- a kit according to any one of aspects 26 to 32, comprising an intermediate layer comprising a metal and inner and outer layers or coatings comprising a polymer.
[Aspect 41]
41. The kit of aspect 40, wherein the inner layer or coating and the outer layer or coating are continuous layers.
[Aspect 42]
41. A kit according to aspect 40, wherein the inner layer or coating and the outer layer or coating are discontinuous layers.
[Aspect 43]
43. The kit of any one of aspects 40-42, wherein the inner layer or coating and the outer layer or coating comprise a material that renders the metal layer non-conductive to the inner or outer surface of the balloon.
[Aspect 44]
44. The kit of any one of aspects 40-43, wherein the outer layer or coating and the inner layer or coating comprise polyurethane, silicone, or poly(p-xylylene).
[Aspect 45]
45. Any one of aspects 40-44, wherein the inner layer or coating of the balloon has a wall thickness of 0.1-100 μm and the outer layer or coating of the balloon has a wall thickness of 0.1-100 μm the kit described [embodiment 46]
33. The kit of any one of aspects 26-32, comprising an inner layer comprising a metal and an outer layer or coating comprising a polymer.
[Aspect 47]
46. The kit of aspect 45, wherein the outer layer or coating comprises a continuous layer.
[Aspect 48]
46. The kit of aspect 45, wherein the outer layer or coating comprises a discontinuous layer.
[Aspect 49]
49. The kit of any one of aspects 46-48, wherein the outer layer or coating comprises a material that renders the metal layer non-conductive to the outer surface of the balloon.
[Aspect 50]
50. The kit of aspect 49, wherein the outer layer or coating comprises polyurethane, silicone, or poly(p-xylylene).
[Aspect 51]
51. The kit of any one of aspects 46-50, wherein the outer layer or coating has a thickness of 0.1-100 μm.
[Aspect 52]
The overall wall thickness of the balloon is 5 to 400 μm [Aspect 53]
The total balloon wall thickness is 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 39. The kit of any one of aspects 26-38, which is 100, 200, 300, or 400 μm.
[Aspect 54]
39. The kit of any one of aspects 26-38, wherein the balloon has an overall wall thickness of 0.0002-0.016 inches.
[Aspect 55]
55. The kit of any one of aspects 26-54, wherein at least a portion of the outer surface of the metal has a rounded, pebbly or granular surface structure.
[Aspect 56]
55. The kit of any one of aspects 26-54, wherein the outer layer comprises a metal, the outer surface of the metal comprising a rounded, pebbled or granular surface structure.
[Aspect 57]
57. A kit according to aspects 55 or 56, wherein the pebbles or granules have a surface height of 0.01-10 μm.
[Aspect 58]
58. The kit of any one of aspects 26-57, wherein at least a portion of the wall of the balloon is formed by electroplating or electroforming.
[Aspect 59]
59. The kit of any one of aspects 26-58, wherein at least a portion of the wall of the balloon is annealed.
[Aspect 60]
60. Any of aspects 26-59, wherein the balloon has sufficient strength to maintain itself in an expanded or partially expanded shape in vivo after separation from the shafts of the first and second members. or the kit according to item 1.
[Aspect 61]
The metal balloon expands or partially expands itself in vivo if no solid or semi-solid material not derived from the patient is present within the central void of the expanded metal balloon after separation from the first and second catheters. 60. The kit of any one of aspects 26-59, wherein the kit has sufficient strength to remain in its dynamically expanded shape.
[Aspect 62]
The expanded metal balloon has sufficient strength to maintain itself in an expanded or partially expanded shape in vivo after separation from the first and second catheters, and the expanded metal balloon has sufficient strength to maintain itself in an expanded or partially expanded shape in vivo. After separation of the balloon and the first and second catheters, the metal balloon is expanded with a solid or semi-solid material or member not derived from the patient to help the metal balloon assume or maintain at least the expanded shape. 60. The kit of any one of aspects 26-59, not requiring a central void or interior volume.
[Aspect 63]
The expanded metal balloon alone has sufficient strength to maintain itself in an expanded or partially expanded shape in vivo after separation from the first and second catheters, aspects 26- 60. The kit of any one of 59.
[Aspect 64]
Embodiments 26-59, wherein after separation of the metal balloon from the first and second catheters in vivo, the pressure within the central void or interior volume of the expanded metal balloon is less than or equal to the pressure outside the expanded metal balloon. The kit according to any one of the above.
[Aspect 65]
60. The kit of any one of aspects 26-59, wherein the polymer and metal balloon are inserted in vivo in an unsealed configuration.
[Aspect 66]
The kit of aspect 1, wherein the wall of the balloon comprises a layer of polymer and a layer of metal, the metal layer having a thickness of 1-300 μm.
[Aspect 67]
67. The kit of aspect 66, wherein the balloon comprises a continuous layer of polymer.
[Aspect 68]
67. The kit of aspect 66, wherein the balloon comprises a discontinuous layer of polymer.
[Aspect 69]
69. The kit of any one of aspects 66-68, wherein the polymer comprises polyethylene terephthalate, polyamide, or polyether block amide.
[Aspect 70]
67. The kit of aspect 66, wherein the balloon comprises a continuous layer of metal.
[Aspect 71]
67. The kit of aspect 66, wherein the balloon comprises a discontinuous layer of metal.
[Aspect 72]
72. The kit of any one of aspects 66, 70, and 71, wherein the metal comprises gold or an alloy thereof.
[Aspect 73]
72. The kit of any one of aspects 66, 70, and 71, wherein the metal comprises platinum, or an alloy thereof.
[Aspect 74]
74. The kit of any one of aspects 66-73, wherein the metal layer is internal to the polymer layer.
[Aspect 75]
74. The kit of any one of aspects 66-73, wherein the metal layer is external to the polymer layer.
[Aspect 76]
76. The kit of aspects 74 or 75, wherein the metal is formed as a wire and configured into a spiral, coil, braid, woven, or linear shape.
[Aspect 77]
77. The kit of aspects 75 or 76, wherein the metal is attached to the underlying polymer by glue or adhesive.
[Aspect 78]
77. The kit of aspects 75 and 76, wherein the metal is attached to the underlying polymer by glue or adhesive.
[Aspect 79]
77. The kit of aspects 75 or 76, wherein the metal is attached or joined to the balloon by an adhesive or glue.
[Aspect 80]
80. The kit of any one of aspects 75-79, comprising the metal layer and one or more additional layers or coatings of polymer external to the first polymer layer and the metal layer.
[Aspect 81]
80. The kit of aspect 79, wherein at least one of the additional polymer layers or coatings is continuous.
[Aspect 82]
80. The kit of aspect 79, wherein at least one of the additional polymer layers or coatings is discontinuous.
[Aspect 83]
83. The kit of any one of aspects 80-82, wherein the additional polymer layer or coating comprises polyurethane, silicone, or poly(p-xylylene).
[Aspect 84]
84. The kit of any one of aspects 76-83, wherein the metal wire is present in at least a portion of the intermediate region of the polymer and the metal balloon.
[Aspect 85]
84. The kit of any one of aspects 76-83, wherein the metal wire is present in at least a portion of the proximal region of the polymer and metal balloon.
[Aspect 86]
84. The kit of any one of aspects 76-83, wherein the metal wire is present in at least a portion of the distal region of the polymer and metal balloon.
[Aspect 87]
84. The kit of any one of aspects 76-83, wherein the metal wire is present in at least a portion of the proximal and intermediate regions of the polymer and metal balloon.
[Aspect 88]
84. The kit of any one of aspects 76-83, wherein the metal wire is present in at least a portion of the distal and intermediate regions of the polymer and metal balloon.
[Aspect 89]
84. The kit of any one of aspects 76-83, wherein the metal wire is present in at least a portion of the proximal, intermediate, and distal regions of the polymer and metal balloon.
[Aspect 90]
91. The kit of any one of aspects 76-90, wherein the cross-sectional shape of the metal wire is circular, oval, square, or rectangular.
[Aspect 91]
91. The kit of any one of aspects 76-90, wherein the metal wire has a diameter or width of 10-1000 μm.
[Aspect 92]
The metal wires are 91. The kit of any one of aspects 76-90, having a diameter or width of 600, 650, 700, 750, 800, 850, 900, 950, or 1000 μm.
[Aspect 93]
93. The kit of any one of aspects 66-92, wherein the overall thickness of the polymer and at least a portion of the balloon wall, including the polymer, metal wire, adhesive, and coating, is 5-1300 μm.
[Aspect 94]
The overall thickness of the polymer and at least a portion of the balloon wall, including the polymer, metal wire, adhesive, and coating, is 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100 ,110,120,130,140,150,200,250,300,350,400,450,500,550,600,650,700,750,800,850,900,950,1000,1050,1100,1150 , 1200, 1250, or 1300 μm.
[Aspect 95]
The polymer and metal balloon has sufficient strength to maintain itself in an expanded or partially expanded shape in vivo after separation from the shafts of the first and second members, aspects 66- 94. The kit of any one of Claims 94.
[Aspect 96]
The polymer and metal balloon can self-sustain itself in vivo if no solid or semi-solid material not derived from the patient is present within the central void of the expanded polymer and metal balloon after separation from the first and second catheters. 95. The kit of any one of aspects 66-94, having sufficient strength to remain in an expanded or partially expanded shape.
[Aspect 97]
The expanded polymer and metal balloon has sufficient strength and expands to maintain itself in an expanded or partially expanded shape in vivo after separation from the first and second catheters. a solid or semi-solid material or member not derived from the patient to help the polymer and metal balloon assume or maintain at least an expanded shape after separation of the polymer and metal balloon and the first and second catheters; within the central void or interior volume of the expanded polymer and metal balloon.
[Aspect 98]
An embodiment wherein the expanded polymer and metal balloon alone has sufficient strength to maintain itself in an expanded or partially expanded shape in vivo after separation from the first and second catheters. The kit according to any one of 66-94.
[Aspect 99]
Embodiment 66, wherein after separation of the polymer and metal balloon from the first and second catheters in vivo, the pressure within the central void or interior volume of the expanded metal balloon is less than or equal to the pressure outside the expanded metal balloon. 94. The kit of any one of claims 1-94.
[Aspect 100]
95. The kit of any one of aspects 66-94, wherein the polymer and metal balloon are inserted in vivo in an unsealed configuration.
[Aspect 101]
101. The kit of any one of aspects 1-100, comprising an expandable metal retention structure, wherein, after expansion, the diameter of a portion of the metal structure is equal to or greater than the diameter of the expanded balloon.
[Aspect 102]
A portion of the expandable metal retention structure is configured to contact the wall of an artery, vein, left atrial appendage, aneurysm, biological conduit, or other blood-containing or biological space, aspect 101. Kit as described.
[Aspect 103]
103. The kit of aspects 101 or 102, wherein the expandable metal retention structure comprises a plurality of elongated ribs extending from the annular structure.
[Aspect 104]
A free end of at least one elongated rib of the expandable metal retaining structure engages a portion of the wall of an artery, vein, left atrial appendage, aneurysm, biological conduit, or other blood-containing or biological space. 104. The kit of aspect 103, comprising a hook or barb configured to.
[Aspect 105]
103. The kit of aspect 101 or and 102, wherein the expandable metal retention structure includes a plurality of elongated ribs extending from the annular structure at opposite ends.
[Aspect 106]
The at least one elongated rib includes hooks or barbs configured to engage a portion of the wall of an artery, vein, left atrial appendage, aneurysm, biological conduit, or other blood-containing or biological space. 106. The kit according to aspect 105.
[Aspect 107]
107. The kit of any one of aspects 101-106, wherein the elongated ribs are laterally biased.
[Aspect 108]
107. The kit of any one of aspects 101-106, wherein the expandable metal retaining structure is self-expanding.
[Aspect 109]
107. The kit of any one of aspects 101-106, wherein the retaining structure comprises Nitinol or stainless steel.
[Aspect 110]
an outer diameter of said annular structure when expanded, measured parallel to a second axis, is between 3 and 40 mm, and a diameter of said balloon when expanded, measured parallel to a second axis, is between 3 and 40 mm; 107. The kit of any one of aspects 101-106, which is 40 mm.
[Aspect 111]
107. The kit of any one of aspects 101-106, wherein one end of the expandable metal retention structure is joined to a distal portion or neck of the balloon.
[Aspect 112]
107. The kit of any one of aspects 101-106, wherein one end of the expandable metal retention structure is joined to the proximal portion or proximal neck of the balloon.
[Aspect 113]
After inflation of the balloon, pulling back the second catheter until the distal tip of the second catheter is positioned within the central void or interior volume of the balloon while the first catheter and balloon remain fixed in place. and passing all or a portion of one or more second medical devices comprising an elongated body, an expandable body, a coagulating fluid or other balloon support material through the second lumen of the second catheter; can be positioned within the central void or interior volume of the balloon,
After expansion of the balloon and placement of all or a portion of one or more second medical devices comprising an elongated body, expandable body, coagulating fluid or other balloon supporting material, the first catheter is separated from the expanded balloon. and removing the first and second catheters from the patient while leaving all or a portion of the balloon and one or more of the elongated bodies, the expandable body, the coagulating fluid or other balloon supporting material within the patient. can be
Further one or more second medical devices comprising an elongated body, an expandable body, or a coagulating fluid, positionable through the lumen of the second catheter and within the biological space adjacent to the balloon. 113. The kit of any one of aspects 1-112, comprising:
[Aspect 114]
a first flexible elongated body, wherein the end of the carrier holding the distal end of the first flexible elongated body is configured for mating to the proximal hub of the second catheter; and 114. The kit of any one of aspects 1-113, comprising a carrier for at least a portion of the second flexible elongated body.
[Aspect 115]
115. The kit of aspect 114, wherein the carrier is configured in a coil shape.
[Aspect 116]
114. Any one of aspects 1-113, wherein a portion of the first flexible elongated body of the second medical device is configured to contact an interior surface of the inflated balloon of the first medical device The kit described in paragraph.
[Aspect 117]
the maximum overall or tertiary diameter of the first flexible elongated body of the second medical device is in the range of 5% less to 20% greater than the maximum diameter of the inflated balloon of the first medical device; 114. The kit of any one of aspects 1-113.
[Aspect 118]
The maximum overall or tertiary diameter of the first flexible elongated body of the second medical device is 1, 2, 3, 4, 5, 6 greater than the maximum diameter of the inflated balloon of the first medical device. , 7, 8, 9, or 10 mm larger.
[Aspect 119]
114. The kit of any one of aspects 1-113, wherein the volume of the first flexible elongate body of the second medical device fills 5-75% of the volume of the central void of the expanded balloon.
[Aspect 120]
The volume of the first flexible elongate body of the second medical device is 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 of the volume of the central void of the expanded balloon, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66. The kit of any one of aspects 1-113, which fills 67, 68, 69, 70, 71, 72, 73, 74, or 75% of the volume of the central void of the expanded balloon.
[Aspect 121]
114. The kit of any one of aspects 1-113, comprising a fourth medical device configured to separate the expanded balloon of the first medical device and the first catheter of the first medical device.
[Aspect 122]
122. The kit of aspect 121, wherein the fourth medical device is configured to form an electrical connection with the first catheter of the first medical device.
[Aspect 123]
122. The kit of aspect 121, wherein the fourth medical device is configured to form an electrical connection with the catheter of the third medical device.
[Aspect 124]
114. Any of aspects 1-113, comprising a fifth medical device configured to separate the first elongate body or expandable body of the second medical device from the second elongate body of the second medical device or the kit according to item 1.
[Aspect 125]
125. The kit of aspect 124, wherein the fifth medical device is configured to form an electrical connection with the second elongate body of the second medical device.
[Aspect 126]
configured to separate the expanded balloon of the first medical device and the first catheter of the first medical device, and the first catheter of the second medical device from the second elongated body of the second medical device; 114. The kit of any one of aspects 1-113, comprising a sixth medical device configured to separate the elongate or expandable body of the.
[Aspect 127]
A sixth medical device configured to form an electrical connection with the first catheter of the first medical device and forms an electrical connection with the second elongated body of the second medical device 127. The kit of aspect 126, configured to:
[Aspect 128]
Between the first catheter of the fourth medical device and the first medical device, between the catheter of the fourth medical device and the third medical device, between the catheter of the fifth medical device and the second medical device configured to provide an electrical connection between the elongated bodies or between a sixth medical device and the first catheter of the first medical device and the second elongated body of the second medical device 128. The kit according to any one of aspects 121-127, comprising a seventh medical device as defined in any one of aspects 121-127.
[Aspect 129]
129. The kit according to aspect 128, wherein the seventh medical device comprises an electrical cable.
[Aspect 130]
130. The kit according to aspect 129, wherein the seventh medical device comprises one or more electrical jacks or connectors.
[Aspect 131]
231. The kit according to aspect 129 or 230, wherein the seventh medical device is configured to apply electrical current to the first medical device, the second medical device, or the third medical device.
[Aspect 132]
132. The kit of any one of aspects 1-131, further comprising a guidewire.
[Aspect 133]
133. The kit of aspect 132, wherein the guidewire has a diameter of 0.010 to 0.038 inches.
[Aspect 134]
the diameter of the guidewire is 0.010, 0.011, 0.012, 0.013, 0.014, 0.015, 0.016, 0.017, 0.018, 0.033, 0.034, 133. The kit of aspect 132, which is 0.035, 0.036, 0.037, or 0.038 inches.
[Aspect 135]
135. The kit of any one of aspects 132-134, wherein the length of the guidewire is at least twice the length of the second catheter of the first medical device.
[Aspect 136]
135. The kit of any one of aspects 132-134, wherein the guidewire is 50-500 cm in length.
[Aspect 137]
135. The kit of any one of aspects 132-134, wherein the guidewire is 200-400 cm in length.
[Aspect 138]
138. The kit of any one of aspects 132-137, wherein the tip of the formed guidewire is angled with respect to the body of the guidewire.
[Aspect 139]
138. The kit of any one of claims 132-137, wherein the tip of the guidewire is formed to be curved with respect to the body of the guidewire.
[Aspect 140]
140. The kit of aspect 139, wherein the curved tip generally forms a J-shape or a C-shape.

Aspects and embodiments relating to methods of manufacturing detachable balloons and detachable devices as disclosed herein:
[Aspect 1]
(1) manufacturing a first catheter;
(2) manufacturing a second catheter;
(3) fabricating a polymeric balloon having a proximal opening thereby forming a first polymeric layer of the polymeric balloon;
(4) expanding the polymer balloon;
(5) applying a first layer of metal having a thickness in the range of 0.0005 to 1 μm to at least a portion of the outer surface of the balloon by a sputter coating or vapor deposition process;
(6) forming the walls of the metallized balloon into a pleated configuration and a folded configuration;
(7) joining or operably coupling the metallized polymer balloon to the first catheter to allow separation of the metallized polymer balloon from the first catheter after expansion within the patient;
The balloon can be pleated and folded,
the distal end of the first catheter can be joined or operably coupled to the opening in the proximal portion of the balloon;
the second catheter passes through the lumen of the first catheter;
the distal portion of the second catheter passes through the opening in the proximal portion of the balloon, the central void or interior volume of the balloon, and the opening in the distal portion of the balloon;
The balloon can be expanded by injecting fluid through the lumen of the first catheter, into the proximal hub of the first catheter, and into the central void or interior volume of the balloon; The expanded balloon can be separated from the first catheter and the first and second catheters can be removed from the patient leaving the expanded balloon within the patient.
a balloon comprising an opening in a proximal portion of the balloon and an opening in a distal portion of the balloon;
A method of manufacturing a medical device for treatment of a human patient, comprising: a first catheter comprising a proximal hub; and a second catheter comprising a proximal hub.
[Aspect 2]
(1) manufacturing a first catheter;
(2) manufacturing a second catheter;
(3) fabricating a polymeric balloon having a proximal opening and a distal opening thereby forming a first polymeric layer of the polymeric balloon;
(4) expanding the polymer balloon;
(5) applying a first layer of metal having a thickness in the range of 0.0005 to 1 μm to at least a portion of the outer surface of the balloon by a sputter coating or vapor deposition process;
(6) applying a second layer of metal having a thickness of 1 to 50 μm to at least a portion of the outer surface of the first metal layer by electroforming or electroplating;
(7) forming the walls of the metallized balloon into a pleated configuration and a folded configuration;
(8) joining or operably coupling the metallized polymer balloon to the first catheter to allow separation of the metallized polymer balloon from the first catheter after expansion within the patient;
The balloon can be pleated and folded,
the distal end of the first catheter can be joined or operably coupled to the opening in the proximal portion of the balloon;
the second catheter passes through the lumen of the first catheter;
the distal portion of the second catheter passes through the opening in the proximal portion of the balloon, the central void or interior volume of the balloon, and the opening in the distal portion of the balloon;
The balloon can be expanded by injecting fluid through the lumen of the first catheter, into the proximal hub of the first catheter, and into the central void or interior volume of the balloon; The expanded balloon can be separated from the first catheter and the first and second catheters can be removed from the patient leaving the expanded balloon within the patient.
a balloon comprising an opening in a proximal portion of the balloon and an opening in a distal portion of the balloon;
A method of manufacturing a medical device for treatment of a human patient, comprising: a first catheter comprising a proximal hub; and a second catheter comprising a proximal hub.
[Aspect 3]
(1) manufacturing a first catheter;
(2) manufacturing a second catheter;
(3) fabricating a polymeric balloon having a proximal opening and a distal opening thereby forming a first polymeric layer of the polymeric balloon;
(4) expanding the polymer balloon;
(5) applying a first adhesive layer to at least a portion of the outer surface of the balloon;
(6) applying a metal wire having a thickness of 25 to 100 μm in a spiral, coil, braid, weave, or linear shape to at least a portion of the adhesive-coated outer surface of the inflated balloon, thereby: forming a first metal layer;
(7) applying a second adhesive layer to at least a portion of the adhesive coated outer surface and at least a portion of the metal wire coated outer surface of the inflated balloon;
(8) drying or curing the adhesive layer;
(9) forming the walls of the metallized balloon into a pleated configuration and a folded configuration;
(10) joining or operably coupling the metallized polymer balloon to the first catheter to allow separation of the metallized polymer balloon from the first catheter after expansion within the patient;
The balloon can be pleated and folded,
the distal end of the first catheter can be joined or operably coupled to the opening in the proximal portion of the balloon;
the second catheter passes through the lumen of the first catheter;
the distal portion of the second catheter passes through the opening in the proximal portion of the balloon, the central void or interior volume of the balloon, and the opening in the distal portion of the balloon;
The balloon can be expanded by injecting fluid through the lumen of the first catheter, into the proximal hub of the first catheter, and into the central void or interior volume of the balloon; The expanded balloon can be separated from the first catheter and the first and second catheters can be removed from the patient leaving the expanded balloon within the patient.
a balloon comprising an opening in a proximal portion of the balloon and an opening in a distal portion of the balloon;
A method of manufacturing a medical device for treatment of a human patient, comprising: a first catheter comprising a proximal hub; and a second catheter comprising a proximal hub.
[Aspect 4]
The method of aspect 1, wherein the first metal layer is gold, titanium, or a combination thereof.
[Aspect 5]
A method according to aspect 1, wherein the balloon comprises a first metal layer that is continuous.
[Aspect 6]
A method according to aspect 1, wherein the balloon comprises a first metal layer that is discontinuous.
[Aspect 7]
7. The method of aspect 6, wherein the first metal layer is formed on the proximal region, the intermediate region, the distal region, the proximal and intermediate regions, the intermediate and distal regions, or the proximal, intermediate and distal regions. .
[Aspect 8]
applying one or more masks to the outer surface of the polymeric balloon prior to forming the first metallic layer such that only a portion of the outer surface of the polymeric balloon is covered by the first metallic layer, or 7. The method of claim 7. Metal layer.
[Aspect 9]
3. The method of aspect 2, wherein the first metal layer comprises gold, titanium, or a combination thereof.
[Aspect 10]
3. The method of aspect 2, wherein the balloon comprises a first metal layer that is continuous.
[Aspect 11]
3. The method of aspect 2, wherein the balloon comprises a first metal layer that is discontinuous.
[Aspect 12]
12. The method of aspect 11, wherein the first metal layer is formed on the proximal region, the intermediate region, the distal region, the proximal and intermediate regions, the intermediate and distal regions, or the proximal, intermediate, and distal regions. the method of.
[Aspect 13]
applying one or more masks to the outer surface of the polymeric balloon prior to forming the first metallic layer such that only a portion of the outer surface of the polymeric balloon is covered by the first metallic layer; or 13. The method of claim 12. The metal layer.
[Aspect 14]
3. The method of aspect 2, wherein the second metal layer comprises gold, platinum, or a combination thereof.
[Aspect 15]
3. The method of aspect 2, wherein the balloon comprises a second metal layer that is continuous.
[Aspect 16]
3. The method of aspect 2, wherein the balloon comprises a second metal layer that is discontinuous.
[Aspect 17]
17. The method of aspect 16, wherein the second metal layer is formed on the proximal region, the intermediate region, the distal region, the proximal and intermediate regions, the intermediate and distal regions, or the proximal, intermediate, and distal regions. the method of.
[Aspect 18]
applying one or more masks to the outer surface of the metallized balloon prior to creating the second metal layer such that only a portion of the outer surface of the metallized balloon is covered by the first metal layer; The method according to 16 or 17.
[Aspect 19]
4. The method of aspect 3, wherein the first layer of adhesive comprises urethane.
[Aspect 20]
20. The method of aspects 3 or 19, wherein the balloon comprises a first adhesive layer that is continuous.
[Aspect 21]
20. The method of aspects 3 or 19, wherein the balloon comprises a first adhesive layer that is discontinuous.
[Aspect 22]
Aspect 21, wherein the first adhesive layer is formed on the proximal region, the intermediate region, the distal region, the proximal and intermediate regions, the intermediate and distal regions, or the proximal, intermediate, and distal regions described method.
[Aspect 23]
One or more masks are applied to the outer surface of the polymeric balloon prior to applying the first layer of adhesive such that only a portion of the outer surface of the polymeric balloon is covered by the first adhesive layer. 23. The method of any one of aspects 3, 21 and 22.
[Aspect 24]
24. The method of any one of aspects 3 and 21-23, wherein the first adhesive layer is formed by immersing the balloon in a solution comprising urethane in a solvent having a urethane concentration in the range of 1-20%. Method.
[Aspect 25]
24. The method of any one of aspects 3 and 21-23, wherein the first adhesive layer is formed by spraying the balloon in a solution comprising urethane in a solvent having a urethane concentration in the range of 1-20%. Method.
[Aspect 26]
26. The method of any one of aspects 3 and 21-25, wherein the first metal layer comprises gold, platinum, iridium, silver, or combinations thereof.
[Aspect 27]
27. The method of aspect 3 or 26, wherein a metal wire is wound onto the expanded balloon.
[Aspect 28]
28. The method of aspect 3 or 27, wherein the wire winding pitch and angle are uniform.
[Aspect 29]
28. The method of aspects 3 or 27, wherein the wire winding pitch and angle are non-uniform.
[Aspect 30]
4. The method of aspect 3, wherein the second layer of adhesive comprises urethane.
[Aspect 31]
20. The method of aspect 3 or 19, wherein the balloon comprises a second adhesive layer that is continuous.
[Aspect 32]
20. The method of aspect 3 or 19, wherein the balloon comprises a second adhesive layer that is discontinuous.
[Aspect 33]
Aspect 21, wherein the second adhesive layer is formed on the proximal region, the intermediate region, the distal region, the proximal and intermediate regions, the intermediate and distal regions, or the proximal, intermediate, and distal regions described method.
[Aspect 34]
One or more masks are applied to the outer surface of the metallized balloon prior to applying the second layer of adhesive such that only a portion of the outer surface of the metallized balloon is covered by the second adhesive layer. 23. The method of any one of aspects 3, 21 and 22, applying.
[Aspect 35]
24. The method of any one of aspects 3 and 21-23, wherein the second adhesive layer is formed by immersing the balloon in a solution comprising urethane in a solvent having a urethane concentration in the range of 1-20%. .
[Aspect 36]
24. The method of any one of aspects 3 and 21-23, wherein the second adhesive layer is formed by spraying the balloon in a solution comprising urethane in a solvent having a urethane concentration in the range of 1-20%. .
[Aspect 37]
32, wherein the second adhesive layer is formed on the proximal region, the intermediate region, the distal region, the proximal and intermediate regions, the intermediate and distal regions, or the proximal, intermediate, and distal regions; described method.
[Aspect 38]
One or more masks are applied to the outer surface of the metallized balloon prior to applying the second layer of adhesive such that only a portion of the outer surface of the metallized balloon is covered by the second adhesive layer. 38. A method according to aspects 32 or 37, wherein:
[Aspect 39]
4. The method of any one of aspects 1-3, wherein the polymeric balloon comprises polyethylene terephthalate (PET), polyamide (nylon), or polyether block amide (Pebax).
[Aspect 40]
4. The method of any one of aspects 1-3, wherein the polymer balloon is manufactured by blow molding.
[Aspect 41]
4. The method of any one of aspects 1-3, forming a balloon having a distal region, a proximal region generally opposite the distal region, and an intermediate region transitioning from the distal region to the proximal region.
[Aspect 42]
4. The method of any one of aspects 1-3, wherein the polymer layer is continuous except for the proximal and distal openings.
[Aspect 43]
1. Any one of aspects 1-3, wherein the polymeric balloon has a rated burst pressure of <30, <25, <20, <15, <10, <5, <4, <3, <2, or <1 atmosphere The method described in the section.
[Aspect 44]
4. The method of any one of aspects 1-3, wherein the polymeric balloon has a single wall thickness of <75, <50, <25, <20, <15, <10, or <5 μm.
[Aspect 45]
4. The method of any one of aspects 1-3, wherein the metallized balloon is formed to form an overall wall having a thickness in the range of 3-175 μm.
[Aspect 46]
4. The method of any one of aspects 1-3, wherein the medical device is manufactured such that at least a portion of the outer surface of the balloon comprises a textured surface.
[Aspect 47]
47. The method of aspect 46, wherein the distance between the highest portion of the outer surface of the balloon and the lowest portion of the outer surface of the balloon is 0.0001-1 μm.
[Aspect 48]
48. The method of manufacture of any one of aspects 1-47, wherein the walls of the metallized balloon are formed into a pleated configuration and a folded configuration prior to bonding or operably coupling the metallized balloon to the first catheter.
[Aspect 49]
48. The method of manufacture of any one of aspects 1-47, wherein after bonding or operably bonding the metallized balloon to the first catheter, the walls of the metallized balloon are formed into a pleated and folded configuration.

Aspects and embodiments relating to methods of treating arteries or veins as disclosed herein:
[Aspect 1]
(a) determining the diameter and length of the artery or vein segment to be treated and having an expanded diameter greater than or equal to the diameter of the selected artery or vein segment and expanding the balloon of the first medical device, the balloon is selected; selecting a first medical device comprising a balloon having an expanded length such that it can occupy at least a portion of the lumen of the arterial and venous segments;
(b) positioning the balloon of the first medical device within the lumen of the selected arterial or venous segment;
(c) delivering a fluid medium through the first lumen into the central void or interior volume of the balloon of the first medical device such that the expanded balloon fills a portion of the lumen of the selected arterial or venous segment; and assuming an expanded configuration in contact with at least a portion of the wall of the arterial or venous segment;
(d) maintaining the position of the expanded balloon of the first medical device while the distal tip of the second catheter of the first medical device is positioned in or within the central void of the expanded balloon of the first medical device; pulling back the second catheter of the first medical device until it is within the volume;
(e) from the proximal end of the second catheter of the first medical device, through the lumen of the second catheter of the first medical device, to the central void or interior volume of the expanded balloon of the first medical device; delivering within the first elongated or expandable body of the second medical device;
(f) separating the first elongated body or expandable body of the second medical device from the second elongated body of the second medical device and the first elongated body or expandable body of the second medical device; (g) removing the second elongated body from the patient while leaving a possible body within the patient; repeating steps (e) and (f) until filled with the elongated body or first expandable body of
(h) separating the expanded balloon of the first medical device from the first catheter of the first medical device and the expanded balloon of the first medical device and the one or more first elongate bodies or first removing the first and second catheters of the first medical device from the patient while leaving the expandable body of
a first medical device comprising:
(i) (i-1) a distal region, generally a proximal region opposite said distal region, an intermediate region transitioning from said distal region to said proximal region, between proximal and distal regions; a first axis extending proximally-distally between and a second axis perpendicular to the first axis;
(i-2) a wall having an outer surface and an inner surface, the inner surface defining a central void or interior volume, extending generally continuously from the proximal region through the intermediate region to the distal region;
(i-3) allow passage of fluid from the first catheter into the central void or interior volume of the balloon and allow passage of a portion of the second catheter into the central void or interior volume of the balloon; an opening in the wall in the proximal region that allows
(i-4) an opening in the wall of the distal region that allows passage of a portion of the second catheter into the central void or interior volume of the balloon;
(i-5) a proximal neck or proximal neck assembly; and
(i-6) a pleated and folded balloon configured for permanent implantation within a human patient comprising a distal neck or distal neck assembly;
(ii) a first lumen for allowing passage of fluid from the proximal end of the first catheter to the distal end of the first catheter and into the central void or interior volume of the balloon; define,
(ii-1) a proximal end including a proximal hub; and
(ii-2) a first catheter comprising a distal portion operably coupled or joined to the proximal neck or proximal neck assembly of the balloon;
(iii) defining a second lumen configured to receive at least one of a guidewire, an elongated body, an expandable body, or a coagulation fluid;
(iii-1) a proximal end including a proximal hub;
(iii-2) a proximal portion passing through the proximal hub of the first catheter;
(iii-3) an intermediate portion passing through the lumen of the first catheter;
(iii-4) a distal portion extending distally to the distal end of the first catheter;
(iii-5) a distal portion passing through the proximal neck or proximal neck assembly of the balloon;
(iii-6) a distal portion passing through the central void or interior volume of the balloon;
(iii-7) a distal portion that engages or passes through a distal neck or distal neck assembly within the balloon; and
(iii-8); a second catheter comprising an open distal end;
(iv) expanding the balloon by passage of fluid through the first catheter and into the central void or interior volume of the balloon;
After inflation of the balloon, the second catheter can be moved forward or backward while the inflated balloon remains fixed in place;
One or more of the first elongate body, the expandable body, the clotting fluid, the solution containing the drug or therapeutic agent, or the embolic particles after expansion of the balloon, including before or after advancing the tip of the second catheter. can be placed through the lumen of the second catheter into the biological space adjacent to the balloon;
After expansion of the balloon, the second catheter can be pulled back until the distal tip of the second catheter is positioned within the central void or interior volume of the balloon, and the one or more first elongate bodies, expanded A possible body, or coagulation fluid, can be passed through the lumen of the second catheter and disposed within the central void or interior volume of the balloon,
the first catheter can be separated from the inflated balloon;
the first and second catheters can be removed from the patient while leaving the balloon and one or more of the first elongate bodies, expandable bodies, or coagulation fluid within the patient;
the second medical device
(i) a distal portion comprising a first elongated or expandable body;
(ii) a proximal portion comprising a second elongated body or delivery system;
including
at least the first elongate body or expandable body of the second medical device after placement of the first elongate body or expandable body of the second medical device within the expanded balloon of the first medical device; contacting at least a portion of the wall of the expanded balloon of the first medical device;
After placement of the first elongated or expandable body of the second medical device within the central void or interior volume of the inflated balloon of the first medical device, but the first the second medical device can be removed from the patient prior to separation of the elongate body or expandable body and the second elongate body of the second medical device;
the first elongated body or expandable body can be separated from the second elongated body;
After separating the first elongate body or expandable body from the second elongate body, removing the second elongate body from the patient while leaving the first elongate body or expandable body within the patient. A method of reducing blood flow in an arterial or venous segment of a human patient using two or more medical devices.
[Aspect 2]
(a) determining the diameter and length of the artery or vein segment to be treated and having an expanded diameter greater than or equal to the diameter of the selected artery or vein segment and expanding the balloon of the first medical device, the balloon is selected; selecting a first medical device comprising a balloon having an expanded length such that it can occupy at least a portion of the lumen of the arterial and venous segments;
(b) positioning the balloon of the first medical device within the lumen of the selected arterial or venous segment;
(c) delivering a fluid medium through the first lumen into the central void or interior volume of the balloon of the first medical device such that the expanded balloon fills a portion of the lumen of the selected arterial or venous segment; and assuming an expanded configuration in contact with at least a portion of the wall of the arterial or venous segment;
(d) from the proximal end of the second catheter of the first medical device, through the lumen of the second catheter of the first medical device, and into an artery or vein adjacent to the inflated balloon of the first medical device; delivering a first elongated or expandable body of a second medical device into the lumen of
(e) maintaining the position of the expanded balloon of the first medical device while the distal tip of the second catheter of the first medical device is in or within the central void of the expanded balloon of the first medical device; pulling back the second catheter of the first medical device until it is within the volume;
(f) contacting at least a portion of the first elongated or expandable body of the second medical device with at least a portion of the walls of the expanded balloon of the first medical device; delivering a first elongated or expandable body of a second medical device into the central void or interior volume of the expanded balloon;
(i) separating the first elongated body or expandable body of the second medical device from the second elongated body of the second medical device and the first elongated body or expandable body of the second medical device; removing the second elongated body from the patient while leaving the possible body within the central void or interior volume of the expanded balloon of the first medical device;
(j) optionally from the proximal end of the second catheter of the first medical device through the lumen of the second catheter of the first medical device to the central void of the expanded balloon of the first medical device; or delivering a first elongated or expandable body of a second medical device within the interior volume;
(k) optionally separating the first elongate body or expandable body of the second medical device from the second elongate body of the second medical device; removing the second elongated body from the patient while leaving the body or expandable body within the central void or interior volume of the expanded balloon of the first medical device;
(l) optionally until a desired percent volume of the unfilled portion of the central void or interior volume of the expanded balloon of the first medical device is filled with the first elongate body or first expandable body; , repeating steps (j) and (k);
(m) separating the expanded balloon of the first medical device from the first catheter of the first medical device and separating the expanded balloon of the first medical device and the one or more first elongated bodies or first removing the first and second catheters of the first medical device from the patient while leaving the expandable body of
a first medical device comprising:
(i) (i-1) a distal region, generally a proximal region opposite said distal region, an intermediate region transitioning from said distal region to said proximal region, between proximal and distal regions; a first axis extending proximally-distally between and a second axis perpendicular to the first axis;
(i-2) a wall having an outer surface and an inner surface, the inner surface defining a central void or interior volume, extending generally continuously from the proximal region through the intermediate region to the distal region;
(i-3) allow passage of fluid from the first catheter into the central void or interior volume of the balloon and allow passage of a portion of the second catheter into the central void or interior volume of the balloon; an opening in the wall in the proximal region that allows
(i-4) an opening in the wall of the distal region that allows passage of a portion of the second catheter into the central void or interior volume of the balloon;
(i-5) a proximal neck or proximal neck assembly; and
(i-6) a pleated and folded balloon configured for permanent implantation within a human patient comprising a distal neck or distal neck assembly;
(ii) a first lumen for allowing passage of fluid from the proximal end of the first catheter to the distal end of the first catheter and into the central void or interior volume of the balloon; define,
(ii-1) a proximal end including a proximal hub; and
(ii-2) a first catheter comprising a distal portion operably coupled or joined to the proximal neck or proximal neck assembly of the balloon;
(iii) defining a second lumen configured to receive at least one of a guidewire, an elongated body, an expandable body, or a coagulation fluid;
(iii-1) a proximal end including a proximal hub;
(iii-2) a proximal portion passing through the proximal hub of the first catheter;
(iii-3) an intermediate portion passing through the lumen of the first catheter;
(iii-4) a distal portion extending distally to the distal end of the first catheter;
(iii-5) a distal portion passing through the proximal neck or proximal neck assembly of the balloon;
(iii-6) a distal portion passing through the central void or interior volume of the balloon;
(iii-7) a distal portion that engages or passes through a distal neck or distal neck assembly within the balloon; and
(iii-8); a second catheter comprising an open distal end;
(iv) expanding the balloon by passage of fluid through the first catheter and into the central void or interior volume of the balloon;
After inflation of the balloon, the second catheter can be moved forward or backward while the inflated balloon remains fixed in place;
One or more of the first elongate body, the expandable body, the clotting fluid, the solution containing the drug or therapeutic agent, or the embolic particles after expansion of the balloon, including before or after advancing the tip of the second catheter. can be placed through the lumen of the second catheter into the biological space adjacent to the balloon;
After expansion of the balloon, the second catheter can be pulled back until the distal tip of the second catheter is positioned within the central void or interior volume of the balloon, and the one or more first elongate bodies, expanded A possible body, or coagulation fluid, can be passed through the lumen of the second catheter and disposed within the central void or interior volume of the balloon,
the first catheter can be separated from the inflated balloon;
the first and second catheters can be removed from the patient while leaving the balloon and one or more of the first elongate bodies, expandable bodies, or coagulation fluid within the patient;
the second medical device
(i) a distal portion comprising a first elongated or expandable body;
(ii) a proximal portion comprising a second elongated body or delivery system;
including
After placement of the first elongated or expandable body of the second medical device into the lumen of the artery or vein adjacent to the inflated balloon of the first medical device, the first elongated body of the second medical device contacting at least a portion of the body or expandable body with at least a portion of the wall of the artery or vein adjacent to the expanded balloon of the first medical device;
after placement of the first elongated or expandable body of the second medical device into the lumen of the artery or vein adjacent to the inflated balloon of the first medical device, but the second medical device can be removed from the patient prior to separation of one elongated body or expandable body and the second elongated body of the second medical device;
the first elongated body or expandable body can be separated from the second elongated body;
After separating the first elongate body or expandable body from the second elongate body, removing the second elongate body from the patient while leaving the first elongate body or expandable body within the patient. A method of reducing blood flow in an arterial or venous segment of a human patient using two or more medical devices.
[Aspect 3] A solution containing a drug or therapeutic agent, or a solution or suspension containing embolic particles A fluoroscopic contrast agent, a solution containing a drug or therapeutic agent, a clotting fluid, a solution or suspension containing embolic particles, or a combination thereof, is first applied prior to being drawn into the central void or interior volume of the inflated balloon. 3. The method of aspect 1 or 2, wherein the infusion is through the lumen of the second catheter of the medical device and into the lumen of an artery or vein adjacent to the inflated balloon of the first medical device.
[Aspect 4]
Drugs, therapeutic agents, clotting fluids, using a syringe or other suitable delivery system, through the lumen of the shaft of the second catheter and into the lumen of the artery or vein adjacent to the inflated balloon of the first medical device. 4. The method of aspect 3, wherein injecting a solution or suspension comprising embolic particles, or a combination thereof.
[Aspect 5]
a solution or solution containing a drug, therapeutic agent, clotting fluid, embolic particles, through the lumen of the shaft of the second catheter of the first medical device and into the lumen of the artery or vein adjacent to the inflated balloon of the first medical device; 5. The method of aspect 3 or 4, wherein prior to injecting the suspension, the second catheter of the first medical device is advanced within the artery or vein while maintaining the position of the balloon of the first medical device. .
[Aspect 6]
coagulating fluid from the proximal end of the first catheter of the first medical device into the first medical device prior to separating the expanded balloon of the first medical device from the first catheter of the first medical device; 3. The method of aspect 1 or 2, wherein injecting through the lumen of the first catheter of and into the central void or interior volume of the inflated balloon of the first medical device.
[Aspect 7]
After being positioned within the central void or interior volume of the expanded balloon, the first elongated or expandable body of the second medical device exerts a force on the wall of the expanded balloon of the first medical device, Aspect 1 7. The method according to any one of 1 to 6.
[Aspect 8]
8. The method of aspect 7, wherein the force on the walls of the expanded balloon of the first medical device is outward.
[Aspect 9]
9. The method of any one of aspects 1-8, wherein the maximum or tertiary diameter of the second medical device is equal to the maximum diameter of the inflated balloon.
[Aspect 10]
from a value in which the maximum diameter or tertiary diameter of the first elongate body or expandable body of the second medical device is equal to the maximum diameter of the expanded balloon of the first medical device to the expanded balloon of the first medical device 9. The method of any one of aspects 1-8, which ranges up to a value that is 50% greater than the maximum diameter of the .
[Aspect 11]
the maximum or tertiary diameter of the first elongate body or expandable body of the second medical device is 1, 2, 3, 4, 5, 6 greater than the maximum diameter of the expanded balloon of the first medical device; 9. The method of any one of aspects 1-8, which is 7, 8, 9, or 10 mm larger.
[Aspect 12]
12. Aspects 1-11 according to any one of aspects 1-11, wherein the volume of the one or more first elongated or expandable bodies of the second medical device fills 5-75% of the volume of the central void of the expanded balloon. the method of.
[Aspect 13]
The volume of the first elongate body or expandable body of the second medical device is 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 of the volume of the central void of the expanded balloon , 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40 , 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65 , 66, 67, 68, 69, 70, 71, 72, 73, 74, or 75%.
[Aspect 14]
The expanded balloon covers at least 100%, 90%, 80%, 70, 60%, 50%, 40%, 30%, 20%, 10%, or 14. The method of any one of aspects 1-13, configured to contact 5%.
[Aspect 15]
The expanded balloon is at least 100%, 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10%, or 15. The method of any one of aspects 1-14, wherein the method is configured to charge 5.
[Aspect 16]
A distal portion of the second catheter of the first medical device includes a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy reveals that the second catheter of the first medical device 16. Any of aspects 1-15, used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal portion of the balloon of the first medical device when moving. 1. The method according to item 1.
[Aspect 17]
A distal portion of the balloon of the first medical device includes a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy reveals that the second catheter of the first medical device is displaced. 17., according to any one of aspects 1 to 16, used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal portion of the balloon of the first catheter. Method.
[Aspect 18]
At least a portion of the distal telescoping structure of the first medical device includes a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy reveals that the second catheter of the first medical device is 18. Any of aspects 1-17, used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal telescoping structure of the first medical device when moving. 1. The method according to item 1.
[Aspect 19]
At least a portion of the first elongated or expandable body of the second medical device is formed from a material that is radiopaque and is clearly visible under fluoroscopy, and fluoroscopy is performed on the second medical device. 19. The method of any one of aspects 1-18, wherein the method is used to monitor placement and position of the first elongate body or expandable body of the.
[Aspect 20]
The second catheter of the first medical device includes one, two, or more radiopaque portions, rings or markers, and fluoroscopy is performed on the first catheter of the second medical device. 20. The method of any one of aspects 1-19, wherein the method is used to monitor the position of the second catheter of the first medical device relative to the position of the elongate body or expandable body.
[Aspect 21]
A distal portion of the first catheter of the first medical device includes a radiopaque marker that is clearly visible under fluoroscopy, and fluoroscopy is used to detect the first medical device from the first catheter of the first medical device. 21. The method of any one of aspects 1-20, wherein the method is used to monitor separation of an inflated balloon of a device.
[Aspect 22]
A proximal portion of the balloon of the first medical device includes radiopaque markers that are clearly visible under fluoroscopy, and fluoroscopy is used to dilate the first medical device from the first catheter of the first medical device. 22. The method of any one of aspects 1-21, wherein the method is used to monitor the detachment of a balloon.
[Aspect 23]
A distal portion of the first catheter of the first medical device includes a radiopaque marker that is clearly visible under fluoroscopy, and fluoroscopy is used to detect the first medical device from the first catheter of the first medical device. 23. The method of any one of aspects 1-22, wherein the method is used to monitor separation of an inflated balloon of a device.
[Aspect 24]
24. The method of any one of aspects 17-23, wherein the radiopaque portion, ring, or marker comprises platinum, iridium, gold, tungsten, or combinations thereof.
[Aspect 25]
25. The method of any one of aspects 1-24, wherein the wall of the artery or vein is damaged or ruptured.
[Aspect 26]
25. The method of any one of aspects 1-24, wherein the wall of the artery or vein is not broken or ruptured.
[Aspect 27]
The second catheter of the first medical device and the distal neck or distal neck assembly of the balloon of the first medical device are coupled by a friction fit, and the second catheter of the first medical device and the first 27. The method of any one of aspects 1-26, wherein the expanded balloon of the medical device is detached by applying axial tension to the tubular segment.
[Aspect 28]
28. The method of aspect 27, wherein the second catheter of the first medical device and the distal neck or distal neck assembly of the balloon of the first medical device are connected by an elastomeric valve.
[Aspect 29]
29. according to aspect 28, wherein the elastomeric valve acts to reduce blood flow through the central void or interior volume of the expanded balloon of the first medical device after removal of the second catheter of the first medical device from the patient. Method.
[Aspect 30]
The first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device are coupled by a friction fit, and the first catheter of the first medical device and the first 30. The method of any one of aspects 1-29, wherein the expanded balloon of the medical device is detached by applying axial tension to the elastomeric tubular segment.
[Aspect 31]
31. The method of aspect 30, wherein the proximal neck or proximal neck assembly of the first catheter of the first medical device and the balloon of the first medical device are joined by an elastomeric tubular segment.
[Aspect 32]
The first catheter of the first medical device and the balloon of the first medical device are joined by a tubular structure, the male portion of the tubular structure is joined to the distal end of the first catheter, and the female tubular structure 30. The method of any one of aspects 1-29, wherein the portion is joined to the proximal neck or proximal neck assembly of the balloon of the first medical device.
[Aspect 33]
33. The method of aspect 32, wherein the proximal neck of the balloon of the first medical device is the second portion of the mechanical latch.
[Aspect 34]
34. The method of aspect 32 or 33, wherein the two portions of the mechanical latch are engaged or operably coupled when the second catheter of the first medical device passes through the mechanical latch.
[Aspect 35]
35. The method of aspect 34, wherein the second catheter of the first medical device is removed from the mechanical latch to separate or operably separate the mechanical latch and the two parts of the mechanical latch.
[Aspect 36]
36. The method of aspect 35, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are pulled apart.
[Aspect 37]
The first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device are joined by an adhesive, glue, or solder, and electrolysis of the first medical device. 30. The method of any one of aspects 1-29, wherein the tubular segment sensitive to erosion is electrolytically eroded.
[Aspect 38]
38. According to aspect 37, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are separated after erosion of a portion of the proximal neck or proximal neck assembly of the balloon of the first medical device. the method of.
[Aspect 39]
The first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device are joined by an adhesive, glue, or solder, and the first catheter of the first medical device. a distal portion of a catheter, a portion of a proximal neck or proximal neck assembly of a balloon of a first medical device, or between a distal portion of a first catheter and a first heat-sensitive tubular segment of a first medical device; 30. The method of any one of aspects 1 to 29, wherein a portion of the bond of is melted by heating.
[Aspect 40]
a distal portion of a first catheter of a first medical device, a proximal neck or proximal neck assembly portion of a balloon of a first medical device, or a distal portion of a first catheter of a first medical device and After melting of a portion of the bond between the proximal neck or proximal neck assembly of the balloon of the first medical device, the first catheter of the first medical device and the expanded balloon of the first medical device are pulled apart. 40. The method of claim 39. The first medical device.
[Aspect 41]
The first elongated body or expandable body of the second medical device is flexible, the second elongated body of the second medical device is flexible, or the 41. The method of any one of aspects 1-40, wherein the first elongate body and the second elongate body are flexible.
[Aspect 42]
The first catheter of the first medical device is flexible and the second catheter of the first medical device is flexible, or the first catheter and the first catheter of the first medical device are flexible. 42. The method of any one of aspects 1-41, wherein the catheter of 2 is flexible.
[Aspect 43]
43. The method of any one of aspects 1-42, wherein the balloon of the first medical device is removable.
[Aspect 44]
44. The method of any one of aspects 1-43, wherein the balloon of the first medical device is deflated or compressed prior to expansion.
[Aspect 45]
44. The method of any one of aspects 1-43, wherein the fluid used to inflate the balloon of the first medical device is water, saline, a fluoroscopic contrast agent, or a combination thereof.
[Aspect 46]
A solution containing a fluoroscopic contrast agent through the second catheter of the first medical device and into the hub of the second catheter of the first medical device and prior to expansion of the balloon of the first medical device. 46. The method of any one of aspects 1-45, wherein the injection is performed under fluoroscopy into an arterial or venous lumen adjacent to the distal tip of the second catheter of the first medical device.
[Aspect 47]
a solution containing a fluoroscopic contrast agent through the second catheter of the first medical device and into the hub of the second catheter of the first medical device and after expansion of the balloon of the first medical device; within the lumen of an artery or vein adjacent to the distal tip of the second catheter of the first medical device, but prior to separation of the balloon of the first medical device and the first catheter of the first medical device 47. The method of any one of aspects 1-46, wherein the injection is performed during fluoroscopy.
[Aspect 48]
A solution containing a fluoroscopic contrast agent is passed through the second catheter of the first medical device, into the hub of the second catheter of the first medical device, and through the balloon of the first medical device and the first medical device. 48. Any one of aspects 1-47, wherein after separation of the first catheter of the device, injection under fluoroscopy into an arterial or venous lumen adjacent to the distal tip of the second catheter of the first medical device. described method.
[Aspect 49]
49. The method of any one of aspects 1-48, further comprising providing a first medical device and one or more second medical devices.

Aspects and embodiments relating to methods of treating an artery or vein with a retention structure as disclosed herein:
[Aspect 1]
(a) determining the diameter and length of the artery or vein segment to be treated and having an expanded diameter greater than or equal to the diameter of the selected artery or vein segment and expanding the balloon of the first medical device, the balloon is selected; selecting a first medical device comprising a balloon having an expanded length such that it can occupy at least a portion of the lumen of the arterial and venous segments;
(b) positioning the balloon of the first medical device within the lumen of the selected arterial or venous segment;
(c) holding the first catheter and balloon of the first medical device in place until the retention structure of the balloon of the first medical device expands and brings a portion of the retention structure into contact with the wall of the artery or vein; (d) optionally applying axial tension on the first catheter after expansion of the retaining structure to stretch the wall of the artery or vein; ensuring attachment of the retaining structure to the
(e) pulling back the third catheter of the first medical device until the balloon of the first medical device is exposed;
(f) delivering a fluid medium through the first lumen into the central void or interior volume of the balloon of the first medical device such that the expanded balloon fills a portion of the lumen of the selected arterial or venous segment; and assuming an expanded configuration in contact with at least a portion of the wall of the arterial or venous segment;
(g) maintaining the position of the expanded balloon of the first medical device while the distal tip of the second catheter of the first medical device is positioned in or within the central void of the expanded balloon of the first medical device; pulling back the second catheter of the first medical device until it is within the volume;
(h) from the proximal end of the second catheter of the first medical device, through the lumen of the second catheter of the first medical device, to the central void or interior volume of the expanded balloon of the first medical device; delivering within the first elongated or expandable body of the second medical device;
(i) separating the first elongated body or expandable body of the second medical device from the second elongated body of the second medical device and the first elongated body or expandable body of the second medical device; removing the second elongated body from the patient while leaving the possible body within the central void or interior volume of the expanded balloon of the first medical device;
(j) optionally, step (h ) and repeating (i);
(k) separating the expanded balloon of the first medical device from the first catheter of the first medical device and separating the expanded balloon of the first medical device and the one or more first elongate bodies or first removing the first and second catheters of the first medical device from the patient while leaving the expandable body of
a first medical device comprising:
(i) (i-1) a distal region, generally a proximal region opposite said distal region, an intermediate region transitioning from said distal region to said proximal region, between proximal and distal regions; a first axis extending proximally-distally between and a second axis perpendicular to the first axis;
(i-2) a wall having an outer surface and an inner surface, the inner surface defining a central void or interior volume, extending generally continuously from the proximal region through the intermediate region to the distal region;
(i-3) allow passage of fluid from the first catheter into the central void or interior volume of the balloon and allow passage of a portion of the second catheter into the central void or interior volume of the balloon; an opening in the wall in the proximal region that allows
(i-4) an opening in the wall of the distal region that allows passage of a portion of the second catheter into the central void or interior volume of the balloon;
(i-5) a proximal neck or proximal neck assembly;
(i-6) a distal neck or distal neck assembly; and
(i-7) Permanently implanted within a human patient comprising a self-expanding metallic retention structure, wherein after expansion, the diameter of at least a portion of the self-expanding metallic retention structure is equal to or greater than the diameter of the expanded balloon. a folded balloon forming pleats configured for;
(ii) a first lumen for allowing passage of fluid from the proximal end of the first catheter to the distal end of the first catheter and into the central void or interior volume of the balloon; define,
(ii-1) a proximal end including a proximal hub;
(ii-2) a proximal portion passing through the proximal hub of the third catheter;
(ii-3) a central portion passing through the lumen of the third catheter;
(ii-4) a distal portion extending distally to the distal end of the third catheter; and
(ii-5) a first catheter comprising a distal portion operably coupled or joined to the proximal neck or proximal neck assembly of the balloon;
(iii) defining a second lumen configured to receive at least one of a guidewire, an elongated body, an expandable body, or a coagulation fluid;
(iii-1) a proximal end including a proximal hub;
(iii-2) a proximal portion passing through the proximal hub of the first catheter;
(iii-3) an intermediate portion passing through the lumen of the first catheter;
(iii-4) a distal portion extending distally to the distal end of the third catheter and the distal end of the first catheter;
(iii-5) a distal portion passing through the proximal neck or proximal neck assembly of the balloon;
(iii-6) a distal portion passing through the central void or interior volume of the balloon;
(iii-7) a distal portion that engages or passes through a distal neck or distal neck assembly within the balloon; and
(iii-8); a second catheter comprising an open distal end;
(iv) partially defining a third lumen for permitting passage of fluid from the proximal end of the third catheter to the distal end of the third catheter; configured to compress the retaining structure;
(iv-1) a proximal end including a proximal hub;
(iv-2); a third catheter comprising an open distal end;
including
(v) moving the third catheter of the first medical device forward or backward while the first catheter, third catheter, and balloon of the first medical device remain fixed in place; ,
the balloon can be expanded by passage of fluid through the first catheter and into the central void or interior volume of the balloon;
After inflation of the balloon, the second catheter can be moved forward or backward while the inflated balloon remains fixed in place;
One or more of the first elongate body, the expandable body, the clotting fluid, the solution containing the drug or therapeutic agent, or the embolic particles after expansion of the balloon, including before or after advancing the tip of the second catheter. can be placed through the lumen of the second catheter into the biological space adjacent to the balloon;
After expansion of the balloon, the second catheter can be pulled back until the distal tip of the second catheter is positioned within the central void or interior volume of the balloon, and the one or more first elongate bodies, expanded A possible body, or coagulation fluid, can be passed through the lumen of the second catheter and disposed within the central void or interior volume of the balloon,
the first catheter can be separated from the inflated balloon;
the first and second catheters can be removed from the patient while leaving the balloon and one or more of the first elongate bodies, expandable bodies, or coagulation fluid within the patient;
the second medical device
(i) a distal portion comprising a first elongated or expandable body;
(ii) a proximal portion comprising a second elongated body or delivery system;
including
at least the first elongate body or expandable body of the second medical device after placement of the first elongate body or expandable body of the second medical device within the expanded balloon of the first medical device; contacting at least a portion of the wall of the expanded balloon of the first medical device;
After placement of the first elongated or expandable body of the second medical device within the central void or interior volume of the inflated balloon of the first medical device, but the first the second medical device can be removed from the patient prior to separation of the elongate body or expandable body and the second elongate body of the second medical device;
the first elongated body or expandable body can be separated from the second elongated body;
After separating the first elongate body or expandable body from the second elongate body, removing the second elongate body from the patient while leaving the first elongate body or expandable body within the patient. A method of reducing blood flow in an arterial or venous segment of a human patient using two or more medical devices.
[Aspect 2]
(a) determining the diameter and length of the artery or vein segment to be treated and having an expanded diameter greater than or equal to the diameter of the selected artery or vein segment and expanding the balloon of the first medical device, the balloon is selected; selecting a first medical device comprising a balloon having an expanded length such that it can occupy at least a portion of the lumen of the arterial and venous segments;
(b) positioning the balloon of the first medical device within the lumen of the selected arterial or venous segment;
(c) holding the first catheter and balloon of the first medical device in place until the retention structure of the balloon of the first medical device expands and brings a portion of the retention structure into contact with the wall of the artery or vein; (d) optionally applying axial tension on the first catheter after expansion of the retaining structure to stretch the wall of the artery or vein; ensuring attachment of the retaining structure to the
(e) pulling back the third catheter of the first medical device until the balloon of the first medical device is exposed;
(f) delivering a fluid medium through the first lumen into the central void or interior volume of the balloon of the first medical device such that the expanded balloon fills a portion of the lumen of the selected arterial or venous segment; and assuming an expanded configuration in contact with at least a portion of the wall of the arterial or venous segment;
(g) from the proximal end of the second catheter of the first medical device, through the lumen of the second catheter of the first medical device, and into an artery or vein adjacent to the inflated balloon of the first medical device; delivering at least a distal portion of the first elongate body or expandable body of the second medical device into the lumen of
(h) maintaining the position of the expanded balloon of the first medical device while the distal tip of the second catheter of the first medical device is positioned in or within the central void of the expanded balloon of the first medical device; pulling back the second catheter of the first medical device until it is within the volume;
(i) a first elongated body of a second medical device or wherein at least a portion of the first elongated body or expandable body contacts at least a portion of a wall of an inflated balloon of the first medical device; delivering the remainder of the expandable body into the central void or interior volume of the expanded balloon of the first medical device;
(j) optionally separating the first elongate body or expandable body of the second medical device from the second elongate body of the second medical device; removing the second elongated body from the patient while leaving the body or expandable body within the central void or interior volume of the expanded balloon of the first medical device;
(k) optionally from the proximal end of the second catheter of the first medical device through the lumen of the second catheter of the first medical device to the central void of the expanded balloon of the first medical device; or delivering a first elongated or expandable body of a second medical device within the interior volume;
(l) optionally separating the first elongate body or expandable body of the second medical device from the second elongate body of the second medical device; removing the second elongated body from the patient while leaving the body or expandable body within the central void or interior volume of the expanded balloon of the first medical device;
(m) optionally until a desired percent volume of the unfilled portion of the central void or interior volume of the expanded balloon of the first medical device is filled with the first elongate body or first expandable body; , repeating steps (k) and (l);
(n) separating the expanded balloon of the first medical device from the first catheter of the first medical device, and separating the expanded balloon of the first medical device and the one or more first elongated bodies or first removing the first and second catheters of the first medical device from the patient while leaving the expandable body of
a first medical device comprising:
(i) (i-1) a distal region, generally a proximal region opposite said distal region, an intermediate region transitioning from said distal region to said proximal region, between proximal and distal regions; a first axis extending proximally-distally between and a second axis perpendicular to the first axis;
(i-2) a wall having an outer surface and an inner surface, the inner surface defining a central void or interior volume, extending generally continuously from the proximal region through the intermediate region to the distal region;
(i-3) allow passage of fluid from the first catheter into the central void or interior volume of the balloon and allow passage of a portion of the second catheter into the central void or interior volume of the balloon; an opening in the wall in the proximal region that allows
(i-4) an opening in the wall of the distal region that allows passage of a portion of the second catheter into the central void or interior volume of the balloon;
(i-5) a proximal neck or proximal neck assembly;
(i-6) a distal neck or distal neck assembly; and
(i-7) Permanently implanted within a human patient comprising a self-expanding metallic retention structure, wherein after expansion, the diameter of at least a portion of the self-expanding metallic retention structure is equal to or greater than the diameter of the expanded balloon. a folded balloon forming pleats configured for;
(ii) a first lumen for allowing passage of fluid from the proximal end of the first catheter to the distal end of the first catheter and into the central void or interior volume of the balloon; define,
(ii-1) a proximal end including a proximal hub;
(ii-2) a proximal portion passing through the proximal hub of the third catheter;
(ii-3) a central portion passing through the lumen of the third catheter;
(ii-4) a distal portion extending distally to the distal end of the third catheter; and
(ii-5) a first catheter comprising a distal portion operably coupled or joined to the proximal neck or proximal neck assembly of the balloon;
(iii) defining a second lumen configured to receive at least one of a guidewire, an elongated body, an expandable body, or a coagulation fluid;
(iii-1) a proximal end including a proximal hub;
(iii-2) a proximal portion passing through the proximal hub of the first catheter;
(iii-3) an intermediate portion passing through the lumen of the first catheter;
(iii-4) a distal portion extending distally to the distal end of the third catheter and the distal end of the first catheter;
(iii-5) a distal portion passing through the proximal neck or proximal neck assembly of the balloon;
(iii-6) a distal portion passing through the central void or interior volume of the balloon;
(iii-7) a distal portion that engages or passes through a distal neck or distal neck assembly within the balloon; and
(iii-8); a second catheter comprising an open distal end;
(iv) partially defining a third lumen for permitting passage of fluid from the proximal end of the third catheter to the distal end of the third catheter; configured to compress the retaining structure;
(iv-1) a proximal end including a proximal hub;
(iv-2); a third catheter comprising an open distal end;
including
(v) moving the third catheter of the first medical device forward or backward while the first catheter, third catheter, and balloon of the first medical device remain fixed in place; ,
the balloon can be expanded by passage of fluid through the first catheter and into the central void or interior volume of the balloon;
After inflation of the balloon, the second catheter can be moved forward or backward while the inflated balloon remains fixed in place;
One or more of the first elongate body, the expandable body, the clotting fluid, the solution containing the drug or therapeutic agent, or the embolic particles after expansion of the balloon, including before or after advancing the tip of the second catheter. can be placed through the lumen of the second catheter into the biological space adjacent to the balloon;
After expansion of the balloon, the second catheter can be pulled back until the distal tip of the second catheter is positioned within the central void or interior volume of the balloon, and the one or more first elongate bodies, expanded A possible body, or coagulation fluid, can be passed through the lumen of the second catheter and disposed within the central void or interior volume of the balloon,
the first catheter can be separated from the inflated balloon;
the first and second catheters can be removed from the patient while leaving the balloon and one or more of the first elongate bodies, expandable bodies, or coagulation fluid within the patient;
the second medical device
(i) a distal portion comprising a first elongated or expandable body;
(ii) a proximal portion comprising a second elongated body or delivery system;
including
After placement of the first elongated or expandable body of the second medical device into the lumen of the artery or vein adjacent to the inflated balloon of the first medical device, the first elongated body of the second medical device contacting at least a portion of the body or expandable body with at least a portion of the wall of the artery or vein adjacent to the expanded balloon of the first medical device;
after placement of the first elongated or expandable body of the second medical device into the lumen of the artery or vein adjacent to the inflated balloon of the first medical device, but the second medical device can be removed from the patient prior to separation of one elongated body or expandable body and the second elongated body of the second medical device;
the first elongated body or expandable body can be separated from the second elongated body;
After separating the first elongate body or expandable body from the second elongate body, removing the second elongate body from the patient while leaving the first elongate body or expandable body within the patient. A method of reducing blood flow in an arterial or venous segment of a human patient using two or more medical devices.
[Aspect 3]
fluoroscopic contrast agent, drug or A solution containing a therapeutic agent, a clotting fluid, a solution or suspension containing embolic particles, or a combination thereof, through the lumen of the second catheter of the first medical device and into the expanded balloon of the first medical device. 3. A method according to aspect 1 or 2, wherein the injection is into the lumen of an adjacent artery or vein.
[Aspect 4]
A solution or suspension containing a fluoroscopic contrast agent, a drug, a therapeutic agent, a clotting fluid, embolic particles, or a combination thereof, through the lumen of the shaft of the second catheter of the first medical device into the first 4. The method of aspect 3, wherein a syringe or other suitable delivery system is used to inject into the lumen of an artery or vein adjacent to the inflated balloon of the medical device.
[Aspect 5]
through the lumen of the shaft of the second catheter of the first medical device and into the lumen of the artery or vein adjacent to the inflated balloon of the first medical device, fluoroscopic contrast agent, drug, therapeutic agent, coagulation fluid or advancing a second catheter of the first medical device within an artery or vein while maintaining the position of the balloon of the first medical device prior to injecting a solution or suspension containing embolic particles; A method according to aspect 3 or 4.
[Aspect 6]
a device wherein coagulation fluid is injected from the proximal end of the first catheter of the first medical device prior to causing the expanded balloon of the first medical device to separate from the first catheter of the first medical device; 3. The method of aspect 1 or 2, through the lumen of the first catheter of the first medical device and into the central void or interior volume of the expanded balloon of the first medical device.
[Aspect 7]
After being positioned within the central void or interior volume of the expanded balloon, the first elongated or expandable body of the second medical device exerts a force on the wall of the expanded balloon of the first medical device, Aspect 1 7. The method according to any one of 1 to 6.
[Aspect 8]
8. The method of aspect 7, wherein the force on the walls of the expanded balloon of the first medical device is outward.
[Aspect 9]
9. The method of any one of aspects 1-8, wherein the maximum or tertiary diameter of the second medical device is equal to the maximum diameter of the inflated balloon.
[Aspect 10]
from a value in which the maximum diameter or tertiary diameter of the first elongate body or expandable body of the second medical device is equal to the maximum diameter of the expanded balloon of the first medical device to the expanded balloon of the first medical device 9. The method of any one of aspects 1-8, which ranges up to a value that is 50% greater than the maximum diameter of the .
[Aspect 11]
the maximum or tertiary diameter of the first elongate body or expandable body of the second medical device is 1, 2, 3, 4, 5, 6 greater than the maximum diameter of the expanded balloon of the first medical device; 9. The method of any one of aspects 1-8, which is 7, 8, 9, or 10 mm larger.
[Aspect 12]
12. Aspects 1-11 according to any one of aspects 1-11, wherein the volume of the one or more first elongated or expandable bodies of the second medical device fills 5-75% of the volume of the central void of the expanded balloon. the method of.
[Aspect 13]
The volume of the first elongate body or expandable body of the second medical device is 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 of the volume of the central void of the expanded balloon , 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40 , 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65 , 66, 67, 68, 69, 70, 71, 72, 73, 74, or 75%.
[Aspect 14]
The expanded balloon covers at least 100%, 90%, 80%, 70, 60%, 50%, 40%, 30%, 20%, 10%, or 5%.
[Aspect 15]
The expanded balloon is at least 100%, 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10%, or 15. The method of any one of aspects 1-14, wherein the method is configured to charge 5.
[Aspect 16]
A distal portion of the second catheter of the first medical device includes a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy reveals that the second catheter of the first medical device 16. Any of aspects 1-15, used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal portion of the balloon of the first medical device when moving. 1. The method according to item 1.
[Aspect 17]
A distal portion of the balloon of the first medical device includes a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy reveals that the second catheter of the first medical device is displaced. 17., according to any one of aspects 1 to 16, used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal portion of the balloon of the first catheter. Method.
[Aspect 18]
At least a portion of the distal telescoping structure of the first medical device includes a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy reveals that the second catheter of the first medical device is 18. Any of aspects 1-17, used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal telescoping structure of the first medical device when moving. 1. The method according to item 1.
[Aspect 19]
At least a portion of the first elongated or expandable body of the second medical device is formed from a material that is radiopaque and is clearly visible under fluoroscopy, and fluoroscopy is performed on the second medical device. 19. The method of any one of aspects 1-18, wherein the method is used to monitor placement and position of the first elongate body or expandable body of the.
[Aspect 20]
The second catheter of the first medical device includes one, two, or more radiopaque portions, rings or markers, and fluoroscopy is performed on the first catheter of the second medical device. 20. The method of any one of aspects 1-19, wherein the method is used to monitor the position of the second catheter of the first medical device relative to the position of the elongate body or expandable body.
[Aspect 21]
A distal portion of the first catheter of the first medical device includes a radiopaque marker that is clearly visible under fluoroscopy, and fluoroscopy is used to detect the first medical device from the first catheter of the first medical device. 21. The method of any one of aspects 1-20, wherein the method is used to monitor separation of an inflated balloon of a device.
[Aspect 22]
A proximal portion of the balloon of the first medical device includes radiopaque markers that are clearly visible under fluoroscopy, and fluoroscopy is used to dilate the first medical device from the first catheter of the first medical device. 22. The method of any one of aspects 1-21, wherein the method is used to monitor the detachment of a balloon.
[Aspect 23]
23. The method of any one of aspects 16-22, wherein the radiopaque portion, ring, or marker comprises platinum, iridium, gold, tungsten, or combinations thereof.
[Aspect 24]
24. The method of any one of aspects 1-23, wherein the wall of the artery or vein is damaged or ruptured.
[Aspect 25]
24. The method of any one of aspects 1-23, wherein the wall of the artery or vein is not broken or ruptured.
[Aspect 26]
The second catheter of the first medical device and the distal neck or distal neck assembly of the balloon of the first medical device are coupled by a friction fit, and the second catheter of the first medical device and the first 26. The method of any one of aspects 1-25, wherein the expanded balloon of the medical device is detached by applying axial tension to the tubular segment.
[Aspect 27]
27. The method of aspect 26, wherein the second catheter of the first medical device and the distal neck or distal neck assembly of the balloon of the first medical device are connected by an elastomeric valve.
[Aspect 28]
28. According to aspect 27, wherein the elastomeric valve acts to reduce blood flow through the central void or interior volume of the expanded balloon of the first medical device after removal of the second catheter of the first medical device from the patient. Method.
[Aspect 29]
The first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device are coupled by a friction fit, and the first catheter of the first medical device and the first 29. The method of any one of aspects 1-28, wherein the expanded balloon of the medical device is detached by applying axial tension to the elastomeric tubular segment.
[Aspect 30]
30. The method of aspect 29, wherein the proximal neck or proximal neck assembly of the first catheter of the first medical device and the balloon of the first medical device are joined by an elastomeric tubular segment.
[Aspect 31]
The first catheter of the first medical device and the balloon of the first medical device are joined by a tubular structure, the male portion of the tubular structure is joined to the distal end of the first catheter, and the female tubular structure 29. The method of any one of aspects 1-28, wherein the portion is joined to the proximal neck or proximal neck assembly of the balloon of the first medical device.
[Aspect 32]
32. The method of aspect 31, wherein the proximal neck of the balloon of the first medical device is the second portion of the mechanical latch.
[Aspect 33]
33. The method of aspect 31 or 32, wherein the two portions of the mechanical latch are engaged or operably coupled when the second catheter of the first medical device passes through the mechanical latch.
[Aspect 34]
34. The method of aspect 33, wherein the second catheter of the first medical device is removed from the mechanical latch to separate or operably separate the mechanical latch and the two parts of the mechanical latch.
[Aspect 35]
34. The method of aspect 33, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are pulled apart.
[Aspect 36]
The first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device are joined by an adhesive, glue, or solder, and electrolysis of the first medical device. 29. The method of any one of aspects 1-28, wherein the tubular segment sensitive to erosion is electrolytically eroded.
[Aspect 37]
37. According to aspect 36, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are pulled apart after erosion of a portion of the proximal neck or proximal neck assembly of the balloon of the first medical device. the method of.
[Aspect 38]
The first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device are joined by an adhesive, glue, or solder, and the first catheter of the first medical device. a distal portion of a catheter, a portion of a proximal neck or proximal neck assembly of a balloon of a first medical device, or between a distal portion of a first catheter and a first heat-sensitive tubular segment of a first medical device; 29. The method of any one of aspects 1-28, wherein a portion of the bond of is melted by heating.
[Aspect 39]
a distal portion of a first catheter of a first medical device, a proximal neck or proximal neck assembly portion of a balloon of a first medical device, or a distal portion of a first catheter of a first medical device and After melting of a portion of the bond between the proximal neck or proximal neck assembly of the balloon of the first medical device, the first catheter of the first medical device and the expanded balloon of the first medical device are pulled apart. 39. The method of claim 38. The first medical device.
[Aspect 40]
40. The method of any one of aspects 1-39, wherein the self-expanding retention structure is joined to the distal neck of the balloon of the first medical device.
[Aspect 41]
40. The method of any one of aspects 1-39, wherein the self-expanding retention structure is joined to the proximal neck of the balloon of the first medical device.
[Aspect 42]
The first elongated body or expandable body of the second medical device is flexible, the second elongated body of the second medical device is flexible, or the 42. The method of any one of aspects 1-41, wherein the first elongate body and the second elongate body are flexible.
[Aspect 43]
The first catheter of the first medical device is flexible and the second catheter of the first medical device is flexible, or the first catheter and the first catheter of the first medical device are flexible. 43. The method of any one of aspects 1-42, wherein the catheter of 2 is flexible.
[Aspect 44]
44. The method of any one of aspects 1-43, wherein the balloon of the first medical device is removable.
[Aspect 45]
45. The method of any one of aspects 1-44, wherein the balloon of the first medical device is deflated or compressed prior to expansion.
[Aspect 46]
46. The method of any one of aspects 1-45, wherein the fluid used to inflate the balloon of the first medical device is water, saline, a fluoroscopic contrast agent, or a combination thereof.
[Aspect 47]
A solution containing a fluoroscopic contrast agent is passed through the second catheter of the first medical device, into the hub of the second catheter of the first medical device, and into the first medical device prior to expansion of the retention structure. 47. The method of any one of aspects 1-46, wherein the injection is performed under fluoroscopy into an arterial or venous lumen adjacent to the distal tip of the second catheter of the device.
[Aspect 48]
a solution containing a fluoroscopic contrast agent through the second catheter of the first medical device, into the hub of the second catheter of the first medical device, and into the retention structure of the balloon of the first medical device; after expansion of the first medical device, but before expansion of the balloon of the first medical device, into the lumen of an artery or vein adjacent to the distal tip of the second catheter of the first medical device under fluoroscopy; 48. The method of any one of aspects 1-47.
[Aspect 49]
a solution containing a fluoroscopic contrast agent through the second catheter of the first medical device and into the hub of the second catheter of the first medical device and after expansion of the balloon of the first medical device; within the lumen of an artery or vein adjacent to the distal tip of the second catheter of the first medical device, but prior to separation of the balloon of the first medical device and the first catheter of the first medical device. 49. The method of any one of aspects 1-48, wherein the injection is performed during fluoroscopy.
[Aspect 50]
A solution containing a fluoroscopic contrast agent is passed through the second catheter of the first medical device, into the hub of the second catheter of the first medical device, and through the expanded balloon of the first medical device and the first catheter. after isolation of the first catheter of the medical device of is injected under fluoroscopy into an arterial or venous lumen adjacent to the distal tip of the second catheter of the first medical device 1. The method according to item 1.
[Aspect 51]
a solution containing a fluoroscopic contrast agent through the third catheter of the first medical device, into the hub of the third catheter of the first medical device, and into the first medical device prior to expansion of the retention structure; 51. The method of any one of aspects 1-50, wherein the injection is performed under fluoroscopy into an arterial or venous lumen adjacent to the distal tip of the third catheter.
[Aspect 52]
a solution containing a fluoroscopic contrast agent through the third catheter of the first medical device, into the hub of the third catheter of the first medical device, and into the retention structure of the balloon of the first medical device; after expansion of the first medical device, but before expansion of the balloon of the first medical device, into the lumen of an artery or vein adjacent to the distal tip of the third catheter of the first medical device under fluoroscopy; 52. The method of any one of aspects 1-51.
[Aspect 53]
a solution containing a fluoroscopic contrast agent through the third catheter of the first medical device and into the hub of the third catheter of the first medical device and after expansion of the balloon of the first medical device; but prior to separation of the inflated balloon of the first medical device and the first catheter of the first medical device, the artery or vein adjacent to the distal tip of the third catheter of the first medical device. 53. The method of any one of aspects 1-52, wherein the injection is intraluminal under fluoroscopy.
[Aspect 54]
A solution containing a fluoroscopic contrast agent is passed through the third catheter of the first medical device, into the hub of the third catheter of the first medical device, and through the expanded balloon of the first medical device and the first catheter. after isolation of the first catheter of the medical device of 1 into the lumen of the artery or vein adjacent to the distal tip of the third catheter of the first medical device under fluoroscopy. 1. The method according to item 1.
[Aspect 55]
55. The method of any one of aspects 1-54, further comprising providing a first medical device and one or more second medical devices.

Aspects and embodiments relating to methods of treating aneurysms, as disclosed herein:
[Aspect 1]
(a) determining a maximum aneurysm neck diameter, a minimum aneurysm width, a minimum aneurysm depth and a minimum aneurysm height, and wherein the inflated balloon diameter is greater than the maximum aneurysm neck diameter;
the dilated balloon diameter is less than the minimum aneurysm width, and
selecting a first medical device comprising: an expanded balloon diameter less than the minimum aneurysm depth; and an expanded balloon diameter less than the minimum aneurysm height;
(b) positioning the balloon of the first medical device within the lumen of the aneurysm;
(c) delivering a fluid medium through the first lumen and into the interior volume of the balloon of the first medical device such that the expanded balloon fills a portion of the aneurysm lumen but the unfilled aneurysm lumen; A step of assuming an extended configuration, leaving a part of
(d) optionally pulling back the expanded balloon of the first medical device until at least a portion of the expanded balloon contacts at least a portion of the aneurysm neck or at least a portion of the aneurysm adjacent to the aneurysm neck; process,
(e) optionally advancing a second catheter of the first medical device into the aneurysm while maintaining the position of the expanded balloon of the first medical device;
(f) from the proximal end of the second catheter of the first medical device through the lumen of the second catheter of the first medical device to the aneurysm lumen adjacent the inflated balloon of the first medical device; delivering the first elongated or expandable body of the second medical device into the unfilled portion of
(g) separating the first elongate body or expandable body of the second medical device from the second elongate body of the second medical device and the first elongate body or expander of the second medical device; removing the second elongated body from the patient while leaving a possible body within the aneurysm lumen;
(h) optionally until a desired percent volume of the unfilled portion of the aneurysm lumen adjacent to the expanded balloon of the first medical device is filled with the first elongate body or first expandable body; , repeating steps (e) and (f);
(i) separating the expanded balloon of the first medical device from the first catheter of the first medical device and the expanded balloon of the first medical device and the one or more first elongated bodies or first removing the first and second catheters of the first medical device from the patient while leaving the expandable body of
a first medical device comprising:
(i) (i-1) a distal region, generally a proximal region opposite said distal region, an intermediate region transitioning from said distal region to said proximal region, between proximal and distal regions; a first axis extending proximally-distally between and a second axis perpendicular to the first axis;
(i-2) a wall having an outer surface and an inner surface, the inner surface defining a central void or interior volume, extending generally continuously from the proximal region through the intermediate region to the distal region;
(i-3) allow passage of fluid from the first catheter into the central void or interior volume of the balloon and allow passage of a portion of the second catheter into the central void or interior volume of the balloon; an opening in the wall in the proximal region that allows
(i-4) an opening in the wall of the distal region that allows passage of a portion of the second catheter into the central void or interior volume of the balloon;
(i-5) a proximal neck or proximal neck assembly; and
(i-6) a pleated and folded balloon configured for permanent implantation within a human patient comprising a distal neck or distal neck assembly;
(ii) a first lumen for allowing passage of fluid from the proximal end of the first catheter to the distal end of the first catheter and into the central void or interior volume of the balloon; define,
(ii-1) a proximal end including a proximal hub; and
(ii-2) a first catheter comprising a distal portion operably coupled or joined to the proximal neck or proximal neck assembly of the balloon;
(iii) defining a second lumen configured to receive at least one of a guidewire, an elongated body, an expandable body, or a coagulation fluid;
(iii-1) a proximal end including a proximal hub;
(iii-2) a proximal portion passing through the proximal hub of the first catheter;
(iii-3) an intermediate portion passing through the lumen of the first catheter;
(iii-4) a distal portion extending distally to the distal end of the first catheter;
(iii-5) a distal portion passing through the proximal neck or proximal neck assembly of the balloon;
(iii-6) a distal portion passing through the central void or interior volume of the balloon;
(iii-7) a distal portion that engages or passes through a distal neck or distal neck assembly within the balloon; and
(iii-8); a second catheter comprising an open distal end;
(iv) expanding the balloon by passage of fluid through the first catheter and into the central void or interior volume of the balloon;
After inflation of the balloon, the second catheter can be moved forward or backward while the inflated balloon remains fixed in place;
One or more of the first elongate body, the expandable body, the clotting fluid, the solution containing the drug or therapeutic agent, or the embolic particles after expansion of the balloon, including before or after advancing the tip of the second catheter. can be placed through the lumen of the second catheter into the biological space adjacent to the balloon;
After expansion of the balloon, the second catheter can be pulled back until the distal tip of the second catheter is positioned within the central void or interior volume of the balloon, and the one or more first elongate bodies, expanded A possible body, or coagulation fluid, can be passed through the lumen of the second catheter and disposed within the central void or interior volume of the balloon,
the first catheter can be separated from the inflated balloon;
the first and second catheters can be removed from the patient while leaving the balloon and one or more of the first elongate bodies, expandable bodies, or coagulation fluid within the patient;
the second medical device
(i) a distal portion comprising a first elongated or expandable body;
(ii) a proximal portion comprising a second elongated body or delivery system;
including
After placement of the first elongated or expandable body of the second medical device into the unfilled portion of the aneurysm lumen adjacent the inflated balloon of the first medical device, the first contacting at least a portion of the elongated or expandable body of the first medical device with at least a portion of the wall of the aneurysm adjacent to the expanded balloon of the first medical device;
after placement of the first elongated or expandable body of the second medical device into the unfilled portion of the aneurysm lumen adjacent the inflated balloon of the first medical device, but the second medical device; the second medical device can be removed from the patient prior to separation of the first elongated body or expandable body of and the second elongated body of the second medical device;
the first elongated body or expandable body can be separated from the second elongated body;
After separating the first elongate body or expandable body from the second elongate body, removing the second elongate body from the patient while leaving the first elongate body or expandable body within the patient. A method of reducing blood flow within a saccular aneurysm in a human patient using two or more medical devices, comprising:
[Aspect 2]
(a) determining a maximum aneurysm neck diameter, a minimum aneurysm width, a minimum aneurysm depth and a minimum aneurysm height, and wherein the inflated balloon diameter is greater than the maximum aneurysm neck diameter;
the dilated balloon diameter is less than the minimum aneurysm width, and
selecting a first medical device comprising: an expanded balloon diameter less than the minimum aneurysm depth; and an expanded balloon diameter less than the minimum aneurysm height;
(b) positioning the balloon of the first medical device within the lumen of the aneurysm;
(c) delivering a fluid medium through the first lumen and into the interior volume of the balloon of the first medical device such that the expanded balloon fills a portion of the aneurysm lumen but the unfilled aneurysm lumen; A step of assuming an extended configuration, leaving a part of
(d) optionally pulling back the expanded balloon of the first medical device until at least a portion of the expanded balloon contacts at least a portion of the aneurysm neck or at least a portion of the aneurysm adjacent to the aneurysm neck; process,
(e) optionally advancing a second catheter of the first medical device into the aneurysm while maintaining the position of the expanded balloon of the first medical device;
(f) from the proximal end of the second catheter of the first medical device through the lumen of the second catheter of the first medical device to the aneurysm lumen adjacent the inflated balloon of the first medical device; delivering at least a distal portion of the first elongate body or expandable body of the second medical device into the unfilled portion of the
(g) while maintaining the position of the expanded balloon of the first medical device, the distal tip of the second catheter of the first medical device is positioned in the central void or interior volume of the expanded balloon of the first medical device; withdrawing the second catheter of the first medical device until it is inside;
(h) contacting at least a portion of the first elongate body or expandable body with at least a portion of the walls of the expanded balloon of the first medical device; or delivering the remainder of the expandable body into the central void or interior volume of the expanded balloon of the first medical device;
(i) separating the first elongated body or expandable body of the second medical device from the second elongated body of the second medical device and the first elongated body or expandable body of the second medical device; removing the second elongated body from the patient while leaving a possible body within the aneurysm lumen;
(j) optionally from the proximal end of the second catheter of the first medical device through the lumen of the second catheter of the first medical device to the central void of the expanded balloon of the first medical device; or delivering a first elongated or expandable body of a second medical device within the interior volume;
(k) optionally separating the first elongate body or expandable body of the second medical device from the second elongate body of the second medical device; removing the second elongated body from the patient while leaving the body or expandable body within the central void or interior volume of the expanded balloon of the first medical device;
(l) optionally until a desired percent volume of the unfilled portion of the central void or interior volume of the expanded balloon of the first medical device is filled with the first elongate body or first expandable body; , repeating steps (j) and (k);
(m) separating the expanded balloon of the first medical device from the first catheter of the first medical device and separating the expanded balloon of the first medical device and the one or more first elongated bodies or first removing the first and second catheters of the first medical device from the patient while leaving the expandable body of
a first medical device comprising:
(i) (i-1) a distal region, generally a proximal region opposite said distal region, an intermediate region transitioning from said distal region to said proximal region, between proximal and distal regions; a first axis extending proximally-distally between and a second axis perpendicular to the first axis;
(i-2) a wall having an outer surface and an inner surface, the inner surface defining a central void or interior volume, extending generally continuously from the proximal region through the intermediate region to the distal region;
(i-3) allow passage of fluid from the first catheter into the central void or interior volume of the balloon and allow passage of a portion of the second catheter into the central void or interior volume of the balloon; an opening in the wall in the proximal region that allows
(i-4) an opening in the wall of the distal region that allows passage of a portion of the second catheter into the central void or interior volume of the balloon;
(i-5) a proximal neck or proximal neck assembly; and
(i-6) a pleated and folded balloon configured for permanent implantation within a human patient comprising a distal neck or distal neck assembly;
(ii) a first lumen for allowing passage of fluid from the proximal end of the first catheter to the distal end of the first catheter and into the central void or interior volume of the balloon; define,
(ii-1) a proximal end including a proximal hub; and
(ii-2) a first catheter comprising a distal portion operably coupled or joined to the proximal neck or proximal neck assembly of the balloon;
(iii) defining a second lumen configured to receive at least one of a guidewire, an elongated body, an expandable body, or a coagulation fluid;
(iii-1) a proximal end including a proximal hub;
(iii-2) a proximal portion passing through the proximal hub of the first catheter;
(iii-3) an intermediate portion passing through the lumen of the first catheter;
(iii-4) a distal portion extending distally to the distal end of the first catheter;
(iii-5) a distal portion passing through the proximal neck or proximal neck assembly of the balloon;
(iii-6) a distal portion passing through the central void or interior volume of the balloon;
(iii-7) a distal portion that engages or passes through a distal neck or distal neck assembly within the balloon; and
(iii-8); a second catheter comprising an open distal end;
(iv) expanding the balloon by passage of fluid through the first catheter and into the central void or interior volume of the balloon;
After inflation of the balloon, the second catheter can be moved forward or backward while the inflated balloon remains fixed in place;
One or more of the first elongate body, the expandable body, the clotting fluid, the solution containing the drug or therapeutic agent, or the embolic particles after expansion of the balloon, including before or after advancing the tip of the second catheter. can be placed through the lumen of the second catheter into the biological space adjacent to the balloon;
After expansion of the balloon, the second catheter can be pulled back until the distal tip of the second catheter is positioned within the central void or interior volume of the balloon, and the one or more first elongate bodies, expanded A possible body, or coagulation fluid, can be passed through the lumen of the second catheter and disposed within the central void or interior volume of the balloon,
the first catheter can be separated from the inflated balloon;
the first and second catheters can be removed from the patient while leaving the balloon and one or more of the first elongate bodies, expandable bodies, or coagulation fluid within the patient;
the second medical device
(i) a distal portion comprising a first elongated or expandable body;
(ii) a proximal portion comprising a second elongated body or delivery system;
including
After placement of the first elongated or expandable body of the second medical device into the unfilled portion of the aneurysm lumen adjacent the inflated balloon of the first medical device, the first contacting at least a portion of the elongated or expandable body of the first medical device with at least a portion of the wall of the aneurysm adjacent to the expanded balloon of the first medical device;
after placement of the first elongated or expandable body of the second medical device into the unfilled portion of the aneurysm lumen adjacent the inflated balloon of the first medical device, but the second medical device; the second medical device can be removed from the patient prior to separation of the first elongated body or expandable body of and the second elongated body of the second medical device;
the first elongated body or expandable body can be separated from the second elongated body;
After separating the first elongate body or expandable body from the second elongate body, removing the second elongate body from the patient while leaving the first elongate body or expandable body within the patient. A method of reducing blood flow within a saccular aneurysm in a human patient using two or more medical devices, comprising:
[Aspect 3]
fluoroscopic contrast agent, drug or Injecting a solution containing a therapeutic agent, a clotting fluid, or a combination thereof through the lumen of the second catheter of the first medical device and into the lumen of the aneurysm adjacent to the inflated balloon of the first medical device. The method according to aspect 1 or 2.
[Aspect 4]
4. The method of aspect 3, wherein a syringe or other suitable delivery system is used to inject the fluoroscopic contrast agent, drug, therapeutic agent, clotting fluid, or combinations thereof.
[Aspect 5]
through the lumen of the shaft of the second catheter of the first medical device and into the lumen of the aneurysm adjacent to the inflated balloon of the first medical device; 5. The method of aspect 3 or 4, wherein the second catheter of the first medical device is advanced within the aneurysm while maintaining the position of the balloon of the first medical device prior to injecting or a combination thereof.
[Aspect 6]
the first catheter of the first medical device from the proximal end of the first catheter of the first medical device prior to separating the expanded balloon of the first medical device from the first catheter of the first medical device; 3. The method of aspect 1 or 2, wherein the coagulation fluid is infused through the lumen of the catheter of and into the central void or interior volume of the inflated balloon of the first medical device.
[Aspect 7]
The expanded balloon contacts at least 100%, 90%, 80%, 70, 60%, 50%, 40%, 30%, 20%, 10%, or 5% of the luminal surface area of the aneurysm. The method of any one of aspects 1-6, wherein the method is configured to:
[Aspect 8]
The expanded balloon fills at least 100%, 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10%, or 5 of the aneurysm lumen volume. The method of any one of aspects 1-6, wherein the method is configured.
[Aspect 9]
9. Aspects 1-8 according to any one of aspects 1-8, wherein the maximum diameter or tertiary diameter of the second medical device is less than or equal to the maximum diameter of the portion of the aneurysm not filled by the expanded balloon of the first medical device. Method.
[Aspect 10]
from a value in which the maximum diameter or tertiary diameter of the first elongate body or expandable body of the second medical device is equal to the maximum diameter of the expanded balloon of the first medical device to the expanded balloon of the first medical device 9. The method of any one of aspects 1-8, wherein the diameter ranges up to 20% greater than the maximum diameter of the portion of the aneurysm that is not filled by the aneurysm.
[Aspect 11]
the maximum or tertiary diameter of the first elongated or expandable body of the second medical device is 1 greater than the maximum diameter of the portion of the aneurysm not filled by the expanded balloon of the first medical device; 11. The method of any one of aspects 1-10, which is 2, 3, 4, 5, 6, 7, 8, 9, or 10 mm larger.
[Aspect 12]
After placement within the aneurysm lumen, at least a portion of the first elongated or expandable body of the second medical device exerts force on the walls of the aneurysm and the expanded balloon of the first medical device. , the method according to any one of aspects 1 to 11.
[Aspect 13]
13. The method of aspect 12, wherein the force of the first elongate body or expandable body against the wall of the expanded balloon pushes the expanded balloon toward the aneurysm neck.
[Aspect 14]
14. The method of any one of aspects 1-13, wherein the maximum or tertiary diameter of the first elongated or expandable body of the second medical device is greater than or equal to the maximum diameter of the expanded balloon.
[Aspect 15]
from a value in which the maximum diameter or tertiary diameter of the first elongate body or expandable body of the second medical device is equal to the maximum diameter of the expanded balloon of the first medical device to the expanded balloon of the first medical device 15. The method of any one of aspects 1 to 14, which ranges up to a value that is 50% greater than the maximum diameter of the .
[Aspect 16]
the maximum or tertiary diameter of the first elongate body or expandable body of the second medical device is 1, 2, 3, 4, 5, 6 greater than the maximum diameter of the expanded balloon of the first medical device; 15. The method of any one of aspects 1-14, which is 7, 8, 9, or 10 mm larger.
[Aspect 17]
After being positioned within the central void or interior volume of the expanded balloon, the first elongated or expandable body of the second medical device exerts a force on the walls of the expanded balloon of the first medical device, aspect 9. 12. The method according to any one of 11.
[Aspect 18]
18. The method of aspect 17, wherein the force on the walls of the expanded balloon of the first medical device is outward.
[Aspect 19]
The volume of the first elongate body or expandable body of the second medical device disposed within the central void or interior volume of the expanded balloon is 5-75% of the volume of the central void or interior volume of the expanded balloon. 19. The method of any one of aspects 1-18, wherein
[Aspect 20]
5, 6, the volume of the first elongate body or expandable body of the second medical device disposed within the central void or interior volume of the expanded balloon is the volume of the central void or interior volume of the expanded balloon; 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, any one of aspects 1-18, satisfying 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, or 75% The method described in the section.
[Aspect 21]
wherein the volume of the first elongate body or expandable body of the second medical device positioned within the lumen of the aneurysm fills 5-75% of the volume of the aneurysm not filled by the expanded balloon. 21. The method according to any one of 1 to 20.
[Aspect 22]
5, 6, 7, 8, wherein the volume of the first elongate body or expandable body of the second medical device positioned within the lumen of the aneurysm is the volume of the aneurysm not filled by the expanded balloon; 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 21. The method of any one of aspects 1-20, wherein the method is 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, or 75% full. .
[Aspect 23]
A distal portion of the second catheter of the first medical device includes a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy reveals that the second catheter of the first medical device 23. Any of aspects 1-22, used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal portion of the balloon of the first medical device when moving. 1. The method according to item 1.
[Aspect 24]
A distal portion of the balloon of the first medical device includes a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy reveals that the second catheter of the first medical device is displaced. , used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal portion of the balloon of the first catheter, according to any one of aspects 1-23. Method.
[Aspect 25]
At least a portion of the distal telescoping structure of the first medical device includes a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy reveals that the second catheter of the first medical device is 25. Any of aspects 1-24, used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal telescoping structure of the first medical device when moving. 1. The method according to item 1.
[Aspect 26]
At least a portion of the first elongated or expandable body of the second medical device is formed from a material that is radiopaque and is clearly visible under fluoroscopy, and fluoroscopy is performed on the second medical device. 26. The method of any one of aspects 1-25, wherein the method is used to monitor placement and position of the first elongate body or expandable body of the.
[Aspect 27]
The second catheter of the first medical device includes one, two, or more radiopaque portions, rings or markers, and fluoroscopy is performed on the first catheter of the second medical device. 27. The method of any one of aspects 1-26, wherein the method is used to monitor the position of the second catheter of the first medical device relative to the position of the elongate body or expandable body.
[Aspect 28]
A distal portion of the first catheter of the first medical device includes a radiopaque marker that is clearly visible under fluoroscopy, and fluoroscopy is used to detect the first medical device from the first catheter of the first medical device. 28. The method of any one of aspects 1-27, wherein the method is used to monitor the separation of an inflated balloon of a device.
[Aspect 29]
A proximal portion of the balloon of the first medical device includes radiopaque markers that are clearly visible under fluoroscopy, and fluoroscopy is used to dilate the first medical device from the first catheter of the first medical device. 29. The method of any one of aspects 1-28, wherein the method is used to monitor the separation of a balloon that has been attached.
[Aspect 30]
30. The method of any one of aspects 23-29, wherein the radiopaque portion, ring, or marker comprises platinum, iridium, gold, tungsten, or combinations thereof.
[Aspect 31]
31. The method of any one of aspects 1-30, wherein the aneurysm wall is damaged or ruptured.
[Aspect 32]
31. The method of any one of aspects 1-30, wherein the aneurysm wall is not broken or ruptured.
[Aspect 33]
The second catheter of the first medical device and the distal neck or distal neck assembly of the balloon of the first medical device are coupled by a friction fit, and the second catheter of the first medical device and the first 33. The method of any one of aspects 1-32, wherein the expanded balloon of the medical device is separated by applying axial tension to the bond.
[Aspect 34]
34. The method of aspect 33, wherein the second catheter of the first medical device and the distal neck or distal neck assembly of the balloon of the first medical device are joined by an elastomeric valve.
[Aspect 35]
35. According to aspect 34, wherein the elastomeric valve acts to reduce blood flow through the central void or interior volume of the expanded balloon of the first medical device after removal of the second catheter of the first medical device from the patient. Method.
[Aspect 36]
The first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device are coupled by a friction fit, and the first catheter of the first medical device and the first 36. The method of any one of aspects 1-35, wherein the expanded balloon of the medical device is separated by applying axial tension to the bond.
[Aspect 37]
37. The method of aspect 36, wherein the proximal neck or proximal neck assembly of the first catheter of the first medical device and the balloon of the first medical device are joined by an elastomeric tubular segment.
[Aspect 38]
A first catheter of the first medical device and a balloon of the first medical device are coupled by a mechanical latch, a portion of the mechanical latch is joined to the distal end of the first catheter, and a first catheter of the mechanical latch. 36. The method of any one of aspects 1-35, wherein two portions are joined to the proximal neck or proximal neck assembly of the balloon of the first medical device.
[Aspect 39]
39. The method of aspect 38, wherein the proximal neck of the balloon of the first medical device is the second portion of the mechanical latch.
[Aspect 40]
40. The method of aspect 38 or 39, wherein the two portions of the mechanical latch are engaged or operably coupled when the second catheter of the first medical device passes through the mechanical latch.
[Aspect 41]
41. The method of aspect 40, wherein the second catheter of the first medical device is removed from the mechanical latch to separate or operably separate the mechanical latch and the two parts of the mechanical latch.
[Aspect 42]
42. The method of aspect 41, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are pulled apart.
[Aspect 43]
The proximal neck or proximal neck assembly of the first catheter of the first medical device and the balloon of the first medical device are joined by an adhesive, glue, or solder, and the proximal neck of the balloon of the first medical device is joined. 43. The method of any one of aspects 1-42, wherein a portion of the proximal neck or proximal neck assembly is electrolytically eroded.
[Aspect 44]
44. According to aspect 43, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are pulled apart after erosion of a portion of the proximal neck or proximal neck assembly of the balloon of the first medical device. the method of.
[Aspect 45]
The first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device are joined by an adhesive, glue, or solder, and the first catheter of the first medical device. the distal portion of the catheter, the proximal neck or portion of the proximal neck assembly of the balloon of the first medical device, or the distal portion of the first catheter of the first medical device and the balloon of the first medical device; 36. The method of any one of aspects 1-35, wherein a portion of the bond between the proximal neck or proximal neck assembly melts upon heating.
[Aspect 46]
a distal portion of a first catheter of a first medical device, a proximal neck or proximal neck assembly portion of a balloon of a first medical device, or a distal portion of a first catheter of a first medical device and After melting of a portion of the bond between the proximal neck or proximal neck assembly of the balloon of the first medical device, the first catheter of the first medical device and the expanded balloon of the first medical device are pulled apart. 46. The method of aspect 45. The first medical device.
[Aspect 47]
47. The method of any one of aspects 1-46, wherein the balloon is deflated or compressed prior to placement within the aneurysm lumen.
[Aspect 48]
3. The method of aspects 1 or 2, wherein the expanded balloon of the first medical device occupies a portion of the aneurysm lumen and reduces blood flow from the parent vessel to the aneurysm lumen.
[Aspect 49]
Aspect 1 or 2, comprising pulling the expanded balloon of the first medical device toward the neck of the aneurysm to obstruct the neck of the aneurysm and reduce blood flow to the aneurysm. Method.
[Aspect 50]
50. The method of aspect 49, comprising pulling the expanded balloon of the first medical device toward the neck of the aneurysm prior to placing the first elongate body or expandable body within the lumen of the aneurysm. .
[Aspect 51]
After positioning the first elongate body or expandable body within the lumen of the aneurysm and after separating the first catheter of the first medical device from the expanded balloon of the first medical device, the first 50. The method of aspect 49, comprising pulling an inflated balloon of the medical device toward the aneurysm neck.
[Aspect 52]
52. The method of any one of aspects 1-51, wherein the expanded balloon of the first medical device fills at least a portion of the lumen of the aneurysm and a portion of the lumen of an adjacent artery.
[Aspect 53]
The first elongated body or expandable body of the second medical device is flexible, the second elongated body of the second medical device is flexible, or the 53. The method of any one of aspects 1-52, wherein the first elongate body and the second elongate body are flexible.
[Aspect 54]
The first catheter of the first medical device is flexible and the second catheter of the first medical device is flexible, or the first catheter and the first catheter of the first medical device are flexible. 53. The method of any one of aspects 1-52, wherein the catheter of 2 is flexible.
[Aspect 55]
55. The method of any one of aspects 1-54, wherein the balloon of the first medical device is removable.
[Aspect 56]
56. The method of any one of aspects 1-55, wherein the balloon of the first medical device is deflated or compressed prior to expansion.
[Aspect 57]
57. The method of any one of aspects 1-56, wherein the fluid used to inflate the balloon of the first medical device is water, saline, a fluoroscopic contrast agent, or a combination thereof.
[Aspect 58]
A solution containing a fluoroscopic contrast agent through the second catheter of the first medical device and into the hub of the second catheter of the first medical device and prior to expansion of the balloon of the first medical device. 58. The method of any one of aspects 1-57, wherein the injection is performed under fluoroscopy into the lumen of the aneurysm adjacent to the distal tip of the second catheter of the first medical device.
[Aspect 59]
a solution containing a fluoroscopic contrast agent through the second catheter of the first medical device and into the hub of the second catheter of the first medical device and after expansion of the balloon of the first medical device; but prior to separation of the expanded balloon of the first medical device and the first catheter of the first medical device, the lumen of the aneurysm adjacent to the distal tip of the second catheter of the first medical device 59. The method of any one of aspects 1-58, wherein the injection is performed under fluoroscopy.
[Aspect 60]
A solution containing a fluoroscopic contrast agent is passed through the second catheter of the first medical device, into the hub of the second catheter of the first medical device, and into the expanded balloon and the first medical device. 60. Any of aspects 1-59, wherein after isolation of the first catheter of one medical device, the second catheter of the first medical device is injected under fluoroscopy into the lumen of the aneurysm adjacent to the distal tip of the second catheter of the first medical device. 1. The method according to item 1.
[Aspect 61]
61. The method of any one of aspects 1-60, further comprising providing a first medical device and one or more second medical devices.

Aspects and embodiments relating to methods of treating the left atrial appendage as disclosed herein:
[Aspect 1]
(a) determining a maximum left atrial appendage neck diameter, a minimum left atrial appendage width, a minimum left atrial appendage depth and a minimum left atrial appendage height, and wherein the expanded balloon diameter is greater than the maximum left atrial appendage neck diameter;
the dilated balloon diameter is less than the minimum left atrial appendage width,
selecting a first medical device comprising: an expanded balloon diameter less than a minimum left atrial appendage depth; and an expanded balloon diameter including an optional retention mechanism less than a minimum left atrial appendage height;
(b) positioning the balloon of the first medical device within the lumen of the left atrial appendage;
(c) holding the first catheter and balloon of the first medical device in place until the retention structure of the balloon of the first medical device expands and brings a portion of the retention structure into contact with the wall of the left atrial appendage; pulling back the third catheter of the first medical device while remaining fixed to the
(d) optionally applying axial tension on the first catheter after expansion of the retention structure to ensure attachment of the retention structure to the wall of the left atrial appendage;
(e) pulling back the third catheter of the first medical device while keeping the first catheter and balloon of the first medical device fixed in place until the balloon of the first medical device is exposed; ,
(f) envision an expanded configuration in which a fluid medium is delivered through the first lumen into the central void or interior volume of the balloon of the first medical device such that the expanded balloon fills a portion of the left atrial appendage lumen; the process of causing
(g) maintaining the position of the expanded balloon of the first medical device while the distal tip of the second catheter of the first medical device is positioned in or within the central void of the expanded balloon of the first medical device; pulling back the second catheter of the first medical device until it is within the volume;
(h) from the proximal end of the second catheter of the first medical device, through the lumen of the second catheter of the first medical device, to the central void or interior volume of the expanded balloon of the first medical device; delivering within the first elongated or expandable body of the second medical device;
(i) separating the first elongated body or expandable body of the second medical device from the second elongated body of the second medical device and the first elongated body or expandable body of the second medical device; removing the second elongated body from the patient while leaving a possible body within the left atrial appendage lumen;
(j) optionally until a desired percent volume of the unfilled portion of the left atrial appendage lumen adjacent to the expanded balloon of the first medical device is filled with the first elongate body or first expandable body; , repeating steps (h) and (i);
(k) separating the expanded balloon of the first medical device from the first catheter of the first medical device and separating the expanded balloon of the first medical device and the one or more first elongate bodies or first removing the first and second catheters of the first medical device from the patient while leaving the expandable body of
a first medical device comprising:
(i) (i-1) a distal region, generally a proximal region opposite said distal region, an intermediate region transitioning from said distal region to said proximal region, between proximal and distal regions; a first axis extending proximally-distally between and a second axis perpendicular to the first axis;
(i-2) a wall having an outer surface and an inner surface, the inner surface defining a central void or interior volume, extending generally continuously from the proximal region through the intermediate region to the distal region;
(i-3) allow passage of fluid from the first catheter into the central void or interior volume of the balloon and allow passage of a portion of the second catheter into the central void or interior volume of the balloon; an opening in the wall in the proximal region that allows
(i-4) an opening in the wall of the distal region that allows passage of a portion of the second catheter into the central void or interior volume of the balloon;
(i-5) a proximal neck or proximal neck assembly;
(i-6) a distal neck or distal neck assembly; and
(i-7) Permanently implanted within a human patient comprising a self-expanding metallic retention structure, wherein after expansion, the diameter of at least a portion of the self-expanding metallic retention structure is equal to or greater than the diameter of the expanded balloon. a folded balloon forming pleats configured for;
(ii) a first lumen for allowing passage of fluid from the proximal end of the first catheter to the distal end of the first catheter and into the central void or interior volume of the balloon; define,
(ii-1) a proximal end including a proximal hub;
(ii-2) a proximal portion passing through the proximal hub of the third catheter;
(ii-3) a central portion passing through the lumen of the third catheter;
(ii-4) a distal portion extending distally to the distal end of the third catheter; and
(ii-5) a first catheter comprising a distal portion operably coupled or joined to the proximal neck or proximal neck assembly of the balloon;
(iii) defining a second lumen configured to receive at least one of a guidewire, an elongated body, an expandable body, or a coagulation fluid;
(iii-1) a proximal end including a proximal hub;
(iii-2) a proximal portion passing through the proximal hub of the first catheter;
(iii-3) an intermediate portion passing through the lumen of the first catheter;
(iii-4) a distal portion extending distally to the distal end of the first catheter;
(iii-5) a distal portion passing through the proximal neck or proximal neck assembly of the balloon;
(iii-6) a distal portion passing through the central void or interior volume of the balloon;
(iii-7) a distal portion that engages or passes through a distal neck or distal neck assembly within the balloon; and
(iii-8); a second catheter comprising an open distal end;
(iv) partially defining a third lumen for permitting passage of fluid from the proximal end of the third catheter to the distal end of the third catheter; configured to compress the retaining structure;
(iv-1) a proximal end including a proximal hub;
(iv-2); a third catheter comprising an open distal end;
including
(v) moving the third catheter of the first medical device forward or backward while the first catheter, third catheter, and balloon of the first medical device remain fixed in place; ,
the balloon can be expanded by passage of fluid through the first catheter and into the central void or interior volume of the balloon;
After inflation of the balloon, the second catheter can be moved forward or backward while the inflated balloon remains fixed in place;
One or more of the first elongate body, the expandable body, the clotting fluid, the solution containing the drug or therapeutic agent, or the embolic particles after expansion of the balloon, including before or after advancing the tip of the second catheter. can be placed through the lumen of the second catheter into the biological space adjacent to the balloon;
After expansion of the balloon, the second catheter can be pulled back until the distal tip of the second catheter is positioned within the central void or interior volume of the balloon, and the one or more first elongate bodies, expanded A possible body, or coagulation fluid, can be passed through the lumen of the second catheter and disposed within the central void or interior volume of the balloon,
the first catheter can be separated from the inflated balloon;
the first and second catheters can be removed from the patient while leaving the balloon and one or more of the first elongate bodies, expandable bodies, or coagulation fluid within the patient;
the second medical device
(i) a distal portion comprising a first elongated or expandable body;
(ii) a proximal portion comprising a second elongated body or delivery system;
including
at least the first elongate body or expandable body of the second medical device after placement of the first elongate body or expandable body of the second medical device within the expanded balloon of the first medical device; contacting at least a portion of the wall of the expanded balloon of the first medical device;
After placement of the first elongated or expandable body of the second medical device within the central void or interior volume of the inflated balloon of the first medical device, but the first the second medical device can be removed from the patient prior to separation of the elongate body or expandable body and the second elongate body of the second medical device;
the first elongated body or expandable body can be separated from the second elongated body;
After separating the first elongate body or expandable body from the second elongate body, removing the second elongate body from the patient while leaving the first elongate body or expandable body within the patient. A method of reducing blood flow in the left atrial appendage of a human patient using two or more medical devices, comprising:
[Aspect 2]
fluoroscopic contrast agent, drug or Injecting a solution containing a therapeutic agent, a clotting fluid, or a combination thereof through the lumen of the second catheter of the first medical device and into the lumen of the left atrial appendage adjacent the inflated balloon of the first medical device. The method according to aspect 1.
[Aspect 3]
3. The method of aspect 2, wherein a syringe or other suitable delivery system is used to inject the fluoroscopic contrast agent, drug, therapeutic agent, clotting fluid, or combinations thereof.
[Aspect 4]
through the lumen of the shaft of the second catheter of the first medical device and into the lumen of the left atrial appendage adjacent the expanded balloon of the first medical device, fluoroscopic contrast agent, drug, therapeutic agent, coagulation fluid, 4. The method of aspect 2 or 3, wherein the second catheter of the first medical device is advanced within the left atrial appendage while maintaining the position of the balloon of the first medical device prior to injecting or a combination thereof.
[Aspect 5]
the second catheter of the first medical device from the proximal end of the second catheter of the first medical device prior to separating the inflated balloon of the first medical device from the first catheter of the first medical device; 3. The method of aspect 1 or 2, wherein the coagulation fluid is infused through the lumen of the catheter of and into the central void or interior volume of the inflated balloon of the first medical device.
[Aspect 6]
The expanded balloon contacts at least 100%, 90%, 80%, 70, 60%, 50%, 40%, 30%, 20%, 10%, or 5% of the area of the luminal surface of the left atrial appendage. The method of any one of aspects 1-5, wherein the method is configured to:
[Aspect 7]
The expanded balloon fills at least 100%, 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10%, or 5 of the volume of the lumen of the left atrial appendage. The method of any one of aspects 1-5, wherein the method is configured.
[Aspect 8]
8. Aspect 1-7 according to any one of aspects 1-7, wherein the maximum diameter or tertiary diameter of the first elongate body or expandable body of the second medical device is less than or equal to the maximum diameter of the expanded balloon of the first medical device. the method of.
[Aspect 9]
from a value in which the maximum diameter or tertiary diameter of the first elongate body or expandable body of the second medical device is equal to the maximum diameter of the expanded balloon of the first medical device to the expanded balloon of the first medical device A method according to any one of aspects 1 to 7, which ranges up to a value that is 50% greater than the maximum diameter of the .
[Aspect 10]
the maximum overall or tertiary diameter of the first elongated or expandable body of the second medical device is 1, 2, 3, 4, 5, 6 greater than the maximum diameter of the expanded balloon of the first medical device , 7, 8, 9, or 10 mm larger.
[Aspect 11]
After being positioned within the central void or interior volume of the expanded balloon, the first elongated or expandable body of the second medical device exerts a force on the wall of the expanded balloon of the first medical device, aspect 8. 11. The method according to any one of 10.
[Aspect 12]
12. The method of aspect 11, wherein the force on the walls of the expanded balloon of the first medical device is outward.
[Aspect 13]
The volume of the first elongate body or expandable body of the second medical device disposed within the central void or interior volume of the expanded balloon is 5-75% of the volume of the central void or interior volume of the expanded balloon. 13. The method of any one of aspects 1-12, wherein
[Aspect 14]
5, 6, the volume of the first elongate body or expandable body of the second medical device disposed within the central void or interior volume of the expanded balloon is the volume of the central void or interior volume of the expanded balloon; 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, any one of aspects 1-12, satisfying 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, or 75% The method described in the section.
[Aspect 15]
A distal portion of the second catheter of the first medical device includes a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy reveals that the second catheter of the first medical device 15. Any of aspects 1-14, used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal portion of the balloon of the first medical device when moving. 1. The method according to item 1.
[Aspect 16]
A distal portion of the balloon of the first medical device includes a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy reveals that the second catheter of the first medical device is displaced. 16., according to any one of aspects 1 to 15, used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal portion of the balloon of the first catheter. Method.
[Aspect 17]
At least a portion of the distal telescoping structure of the first medical device includes a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy reveals that the second catheter of the first medical device is 17. Any of aspects 1-16, used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal telescoping structure of the first medical device when moving. 1. The method according to item 1.
[Aspect 18]
At least a portion of the first elongated or expandable body of the second medical device is formed from a material that is radiopaque and is clearly visible under fluoroscopy, and fluoroscopy is performed on the second medical device. 18. The method of any one of aspects 1-17, wherein the method is used to monitor placement and position of the first elongate body or expandable body of the.
[Aspect 19]
The second catheter of the first medical device includes one, two, or more radiopaque portions, rings or markers, and fluoroscopy is performed on the first catheter of the second medical device. 19. The method of any one of aspects 1-18, wherein the method is used to monitor the position of the second catheter of the first medical device relative to the position of the elongate body or expandable body.
[Aspect 20]
A distal portion of the first catheter of the first medical device includes a radiopaque marker that is clearly visible under fluoroscopy, and fluoroscopy is used to detect the first medical device from the first catheter of the first medical device. 20. The method of any one of aspects 1-19, wherein the method is used to monitor the separation of an inflated balloon of a device.
[Aspect 21]
A proximal portion of the balloon of the first medical device includes radiopaque markers that are clearly visible under fluoroscopy, and fluoroscopy is used to dilate the first medical device from the first catheter of the first medical device. 21. The method of any one of aspects 1-20, wherein the method is used to monitor the detachment of a balloon.
[Aspect 22]
22. The method of any one of aspects 15-21, wherein the radiopaque portion, ring, or marker comprises platinum, iridium, gold, tungsten, or combinations thereof.
[Aspect 23]
The second catheter of the first medical device and the distal neck or distal neck assembly of the balloon of the first medical device are coupled by a friction fit, and the second catheter of the first medical device and the first 23. The method of any one of aspects 1-22, wherein the expanded balloon of the medical device is separated by applying axial tension to the bond.
[Aspect 24]
24. The method of aspect 23, wherein the second catheter of the first medical device and the distal neck or distal neck assembly of the balloon of the first medical device are joined by an elastomeric valve.
[Aspect 25]
25. According to aspect 24, wherein the elastomeric valve acts to reduce blood flow through the central void or interior volume of the expanded balloon of the first medical device after removal of the second catheter of the first medical device from the patient. Method.
[Aspect 26]
The first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device are coupled by a friction fit, and the first catheter of the first medical device and the first 26. The method of any one of aspects 1-25, wherein the expanded balloon of the medical device is separated by applying axial tension to the bond.
[Aspect 27]
27. The method of aspect 26, wherein the proximal neck or proximal neck assembly of the first catheter of the first medical device and the balloon of the first medical device are joined by an elastomeric tubular segment.
[Aspect 28]
A first catheter of the first medical device and a balloon of the first medical device are coupled by a mechanical latch, a portion of the mechanical latch is joined to the distal end of the first catheter, and a first catheter of the mechanical latch. 26. The method of any one of aspects 1-25, wherein two portions are joined to the proximal neck or proximal neck assembly of the balloon of the first medical device.
[Aspect 29]
29. The method of aspect 28, wherein the proximal neck of the balloon of the first medical device is the second portion of the mechanical latch.
[Aspect 30]
30. The method of aspect 28 or 29, wherein the two portions of the mechanical latch are engaged or operably coupled when the second catheter of the first medical device passes through the mechanical latch.
[Aspect 31]
31. The method of aspect 30, wherein the second catheter of the first medical device is removed from the mechanical latch to separate or operably separate the mechanical latch and the two parts of the mechanical latch.
[Aspect 32]
32. The method of aspect 31, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are separated.
[Aspect 33]
The proximal neck or proximal neck assembly of the first catheter of the first medical device and the balloon of the first medical device are joined by an adhesive, glue, or solder, and the proximal neck of the balloon of the first medical device is joined. 33. The method of any one of aspects 1-32, wherein a portion of the proximal neck or proximal neck assembly is electrolytically eroded.
[Aspect 34]
34. According to aspect 33, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are separated after erosion of a portion of the proximal neck or proximal neck assembly of the balloon of the first medical device. the method of.
[Aspect 35]
The first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device are joined by an adhesive, glue, or solder, and the first catheter of the first medical device. the distal portion of the catheter, the proximal neck or portion of the proximal neck assembly of the balloon of the first medical device, or the distal portion of the first catheter of the first medical device and the balloon of the first medical device; 26. The method of any one of aspects 1-25, wherein a portion of the bond between the proximal neck or proximal neck assembly melts upon heating.
[Aspect 36]
a distal portion of a first catheter of a first medical device, a proximal neck or proximal neck assembly portion of a balloon of a first medical device, or a distal portion of a first catheter of a first medical device and After melting of a portion of the bond between the proximal neck or proximal neck assembly of the balloon of the first medical device, the first catheter of the first medical device and the expanded balloon of the first medical device are pulled apart. 36. The method of aspect 35. The first medical device.
[Aspect 37]
37. The method of any one of aspects 1-36, wherein the balloon is deflated or compressed prior to placement within the lumen of the left atrial appendage.
[Aspect 38]
The method of aspect 1, wherein the expanded balloon of the first medical device occupies a portion of the lumen of the left atrial appendage to reduce blood flow from the right atrium to the lumen of the left atrial appendage.
[Aspect 39]
39. The method of any one of aspects 1-38, wherein the expanded balloon of the first medical device fills at least a portion of the lumen of the left atrial appendage and a portion of the lumen of the adjacent left atrium.

[Aspect 40]
40. The method of any one of aspects 1-39, wherein the self-expanding retention structure is joined to the distal neck of the balloon of the first medical device.
[Aspect 41]
The first elongated body or expandable body of the second medical device is flexible, the second elongated body of the second medical device is flexible, or the 41. The method of any one of aspects 1-40, wherein the first elongate body and the second elongate body are flexible.
[Aspect 42]
A first catheter of the first medical device is flexible, a second catheter of the first medical device is flexible, and a third catheter of the first medical device is flexible or wherein the first, second and third catheters of the first medical device are flexible.
[Aspect 43]
43. The method of any one of aspects 1-42, wherein the balloon of the first medical device is removable.
[Aspect 44]
44. The method of any one of aspects 1-43, wherein the balloon of the first medical device is deflated or compressed prior to expansion.
[Aspect 45]
45. The method of any one of aspects 1-44, wherein the fluid used to inflate the balloon of the first medical device is water, saline, a fluoroscopic contrast agent, or a combination thereof.
[Aspect 46]
A solution containing a fluoroscopic contrast agent is passed through the second catheter of the first medical device, into the hub of the second catheter of the first medical device, and into the first medical device prior to expansion of the retention structure. 46. The method of any one of aspects 1-45, wherein injecting under fluoroscopy into the lumen of the left atrial appendage adjacent the distal tip of the second catheter of the device.
[Aspect 47]
a solution containing a fluoroscopic contrast agent through the second catheter of the first medical device, into the hub of the second catheter of the first medical device, and into the retention structure of the balloon of the first medical device; after expansion of the first medical device, but before expansion of the balloon of the first medical device, into the lumen of the left atrial appendage adjacent to the tip of the second catheter of the first medical device under fluoroscopy. 47. The method of any one of 46.
[Aspect 48]
a solution containing a fluoroscopic contrast agent through the second catheter of the first medical device and into the hub of the second catheter of the first medical device and after balloon expansion of the first medical device. within the lumen of the left atrial appendage adjacent to the distal tip of the second catheter of the first medical device after separation of the expanded balloon of the first medical device and the first catheter of the first medical device 48. The method of any one of aspects 1-47, wherein the injection is performed during fluoroscopy.
[Aspect 49]
A solution containing a fluoroscopic contrast agent is passed through the second catheter of the first medical device, into the hub of the second catheter of the first medical device, and into the expanded balloon and the first medical device. 49. Any of aspects 1-48, wherein after isolation of the first catheter of one medical device, injection is performed under fluoroscopy into the lumen of the left atrial appendage adjacent to the distal tip of the second catheter of the first medical device. 1. The method according to item 1.
[Aspect 50]
a solution containing a fluoroscopic contrast agent through the third catheter of the first medical device, into the hub of the third catheter of the first medical device, and prior to expansion of the retention structure; 50. The method of any one of aspects 1-49, wherein the injection is performed under fluoroscopy into the lumen of the left atrial appendage adjacent to the distal tip of the third catheter of the medical device.
[Aspect 51]
a solution containing a fluoroscopic contrast agent through the third catheter of the first medical device, into the hub of the third catheter of the first medical device, and into the retention structure of the balloon of the first medical device; but after expansion of the balloon of the first medical device, into the lumen of the left atrial appendage adjacent to the distal tip of the third catheter of the first medical device under fluoroscopy. 50. The method of any one of claims 1 to 50.
[Aspect 52]
a solution containing a fluoroscopic contrast agent through the third catheter of the first medical device and into the hub of the third catheter of the first medical device and after expansion of the balloon of the first medical device; but prior to separation of the expanded balloon of the first medical device and the first catheter of the first medical device, the lumen of the left atrial appendage adjacent the distal tip of the third catheter of the first medical device. 52. The method of any one of aspects 1-51, wherein the injection is performed under fluoroscopy.
[Aspect 53]
A solution containing a fluoroscopic contrast agent is passed through the third catheter of the first medical device, into the hub of the third catheter of the first medical device, and into the expanded balloon and the first medical device. 53. Any of aspects 1-52, wherein, after isolation of the first catheter of one medical device, is injected under fluoroscopy into the lumen of the left atrial appendage adjacent to the distal tip of the third catheter of the first medical device. 1. The method according to item 1.
[Aspect 54]
54. The method of any one of aspects 1-53, further comprising providing a first medical device and one or more second medical devices.

Aspects and embodiments relating to methods of treating a paravalvular leak using a detachable balloon catheter as disclosed herein:
[Aspect 1]
(a) determining the diameter and length of the segment of the paravalvular leak tract to be treated and, when the balloon of the first medical device is inflated, the expanded diameter equal to or greater than the diameter of the selected segment of the paravalvular leak tract; and selecting a first medical device comprising a balloon having an expanded length such that the balloon can occupy at least a portion of the lumen of the paravalvular leak pathway;
(b) positioning the balloon of the first medical device within the lumen of the paravalvular leak path;
(c) delivering a fluid medium through the first lumen and into the interior volume of the balloon of the first medical device such that the expanded balloon fills a portion of the lumen of the paravalvular leak pathway and reduces the paravalvular leak; assuming an extended configuration contacting at least a portion of the wall of the passageway;
(d) maintaining the position of the expanded balloon of the first medical device while the distal tip of the second catheter of the first medical device is positioned in or within the central void of the expanded balloon of the first medical device; pulling back the second catheter of the first medical device until it is within the volume;
(e) from the proximal end of the second catheter of the first medical device, through the lumen of the second catheter of the first medical device, to the central void or interior volume of the expanded balloon of the first medical device; delivering within the first elongated or expandable body of the second medical device;
(f) separating the first elongated body or expandable body of the second medical device from the second elongated body of the second medical device and the first elongated body or expandable body of the second medical device; removing the second elongated body from the patient while leaving a possible body within the patient;
(g) steps (e) and ( repeating f);
(h) separating the expanded balloon of the first medical device from the first catheter of the first medical device; removing the first and second catheters of the first medical device from the patient while leaving the elongated body or first expandable body of the patient within the patient;
a first medical device comprising:
(i) (i-1) a distal region, generally a proximal region opposite said distal region, an intermediate region transitioning from said distal region to said proximal region, between proximal and distal regions; a first axis extending proximally-distally between and a second axis perpendicular to the first axis;
(i-2) a wall having an outer surface and an inner surface, the inner surface defining a central void or interior volume, extending generally continuously from the proximal region through the intermediate region to the distal region;
(i-3) allow passage of fluid from the first catheter into the central void or interior volume of the balloon and allow passage of a portion of the second catheter into the central void or interior volume of the balloon; an opening in the wall in the proximal region that allows
(i-4) an opening in the wall of the distal region that allows passage of a portion of the second catheter into the central void or interior volume of the balloon;
(i-5) a proximal neck or proximal neck assembly; and
(i-6) a pleated and folded balloon configured for permanent implantation within a human patient comprising a distal neck or distal neck assembly;
(ii) a first lumen for allowing passage of fluid from the proximal end of the first catheter to the distal end of the first catheter and into the central void or interior volume of the balloon; define,
(ii-1) a proximal end including a proximal hub; and
(ii-2) a first catheter comprising a distal portion operably coupled or joined to the proximal neck or proximal neck assembly of the balloon;
(iii) defining a second lumen configured to receive at least one of a guidewire, an elongated body, an expandable body, or a coagulation fluid;
(iii-1) a proximal end including a proximal hub;
(iii-2) a proximal portion passing through the proximal hub of the first catheter;
(iii-3) an intermediate portion passing through the lumen of the first catheter;
(iii-4) a distal portion extending distally to the distal end of the first catheter;
(iii-5) a distal portion passing through the proximal neck or proximal neck assembly of the balloon;
(iii-6) a distal portion passing through the central void or interior volume of the balloon;
(iii-7) a distal portion that engages or passes through a distal neck or distal neck assembly within the balloon; and
(iii-8); a second catheter comprising an open distal end;
including
(iv) expanding the balloon by passage of fluid through the first catheter and into the central void or interior volume of the balloon;
After inflation of the balloon, the second catheter can be moved forward or backward while the inflated balloon remains fixed in place;
One or more of the first elongate body, the expandable body, the clotting fluid, the solution containing the drug or therapeutic agent, or the embolic particles after expansion of the balloon, including before or after advancing the tip of the second catheter. can be placed through the lumen of the second catheter into the biological space adjacent to the balloon;
After expansion of the balloon, the second catheter can be pulled back until the distal tip of the second catheter is positioned within the central void or interior volume of the balloon, and the one or more first elongate bodies, expanded A possible body, or coagulation fluid, can be passed through the lumen of the second catheter and disposed within the central void or interior volume of the balloon,
the first catheter can be separated from the inflated balloon;
the first and second catheters can be removed from the patient while leaving the balloon and one or more of the first elongate bodies, expandable bodies, or coagulation fluid within the patient;
the second medical device
(i) a distal portion comprising a first elongated or expandable body;
(ii) a proximal portion comprising a second elongated body or delivery system;
including
at least the first elongate body or expandable body of the second medical device after placement of the first elongate body or expandable body of the second medical device within the expanded balloon of the first medical device; contacting at least a portion of the wall of the expanded balloon of the first medical device;
After placement of the first elongated or expandable body of the second medical device within the central void or interior volume of the inflated balloon of the first medical device, but the first the second medical device can be removed from the patient prior to separation of the elongate body or expandable body and the second elongate body of the second medical device;
the first elongated body or expandable body can be separated from the second elongated body;
After separating the first elongate body or expandable body from the second elongate body, removing the second elongate body from the patient while leaving the first elongate body or expandable body within the patient. A method of reducing blood flow in a paravalvular leak pathway in a human patient using two or more medical devices, comprising:
[Aspect 2]
the second catheter of the first medical device from the proximal end of the second catheter of the first medical device prior to separating the inflated balloon of the first medical device from the first catheter of the first medical device; A method according to aspect 1, wherein the coagulation fluid is infused through the catheter lumen of the first medical device and into the central void or interior volume of the inflated balloon of the first medical device.
[Aspect 3]
After being positioned within the central void or interior volume of the expanded balloon, the first elongated or expandable body of the second medical device exerts a force on the wall of the expanded balloon of the first medical device, Aspect 1 Or the method of 2 description.
[Aspect 4]
4. The method of aspect 3, wherein the force on the walls of the expanded balloon of the first medical device is outward.
[Aspect 5]
5. The method of any one of aspects 1-4, wherein the maximum or tertiary diameter of the second medical device is equal to the maximum diameter of the inflated balloon.
[Aspect 6]
from a value in which the maximum diameter or tertiary diameter of the first elongate body or expandable body of the second medical device is equal to the maximum diameter of the expanded balloon of the first medical device to the expanded balloon of the first medical device 5. The method of any one of aspects 1-4, which ranges up to a value that is 50% greater than the maximum diameter of the .
[Aspect 7]
the maximum overall or tertiary diameter of the first elongated or expandable body of the second medical device is 1, 2, 3, 4, 5, 6 greater than the maximum diameter of the expanded balloon of the first medical device , 7, 8, 9, or 10 mm.
[Aspect 8]
8. Aspects 1-7 according to any one of aspects 1-7, wherein the volume of the one or more first elongated or expandable bodies of the second medical device fills 5-75% of the volume of the central void of the expanded balloon. the method of.
[Aspect 9]
The volume of the first elongate body or expandable body of the second medical device is 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 of the volume of the central void of the expanded balloon , 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40 , 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65 , 66, 67, 68, 69, 70, 71, 72, 73, 74, or 75%.
[Aspect 10]
A distal portion of the second catheter of the first medical device includes a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy reveals that the second catheter of the first medical device 10. Any of aspects 1-9, used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal portion of the balloon of the first medical device when moving. 1. The method according to item 1.
[Aspect 11]
A distal portion of the balloon of the first medical device includes a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy reveals that the second catheter of the first medical device is displaced. 11., according to any one of aspects 1 to 10, used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal portion of the balloon of the first catheter. Method.
[Aspect 12]
At least a portion of the distal telescoping structure of the first medical device includes a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy reveals that the second catheter of the first medical device is 12. Any of aspects 1-11, used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal telescoping structure of the first medical device when moving. 1. The method according to item 1.
[Aspect 13]
At least a portion of the first elongated or expandable body of the second medical device is formed from a material that is radiopaque and is clearly visible under fluoroscopy, and fluoroscopy is performed on the second medical device. 13. The method of any one of aspects 1-12, wherein the method is used to monitor placement and position of the first elongate body or expandable body of the.
[Aspect 14]
The second catheter of the first medical device includes one, two, or more radiopaque portions, rings or markers, and fluoroscopy is performed on the first catheter of the second medical device. 14. The method of any one of aspects 1-13, wherein the method is used to monitor the position of the second catheter of the first medical device relative to the position of the elongate body or expandable body.
[Aspect 15]
A distal portion of the first catheter of the first medical device includes a radiopaque marker that is clearly visible under fluoroscopy, and fluoroscopy is used to detect the first medical device from the first catheter of the first medical device. 15. The method of any one of aspects 1-14, wherein the method is used to monitor separation of an inflated balloon of a device.
[Aspect 16]
A proximal portion of the balloon of the first medical device includes radiopaque markers that are clearly visible under fluoroscopy, and fluoroscopy is used to dilate the first medical device from the first catheter of the first medical device. 16. The method of any one of aspects 1-15, wherein the method is used to monitor the detachment of a balloon.
[Aspect 17]
17. The method of any one of aspects 10-16, wherein the radiopaque portion, ring, or marker comprises platinum, iridium, gold, tungsten, or combinations thereof.
[Aspect 18]
The second catheter of the first medical device and the distal neck or distal neck assembly of the balloon of the first medical device are coupled by a friction fit, and the second catheter of the first medical device and the first 18. The method of any one of aspects 1-17, wherein the expanded balloon of the medical device is separated by applying axial tension to the bond.
[Aspect 19]
19. The method of aspect 18, wherein the second catheter of the first medical device and the distal neck or distal neck assembly of the balloon of the first medical device are joined by an elastomeric valve.
[Aspect 20]
20. according to aspect 19, wherein the elastomeric valve acts to reduce blood flow through the central void or interior volume of the expanded balloon of the first medical device after removal of the second catheter of the first medical device from the patient. Method.
[Aspect 21]
The first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device are coupled by a friction fit, and the first catheter of the first medical device and the first 21. The method of any one of aspects 1-20, wherein the expanded balloon of the medical device is separated by applying axial tension to the bond.
[Aspect 22]
22. The method of aspect 21, wherein the proximal neck or proximal neck assembly of the first catheter of the first medical device and the balloon of the first medical device are joined by an elastomeric tubular segment.
[Aspect 23]
A first catheter of the first medical device and a balloon of the first medical device are coupled by a mechanical latch, a portion of the mechanical latch is joined to the distal end of the first catheter, and a first catheter of the mechanical latch. 21. The method of any one of aspects 1-20, wherein two portions are joined to the proximal neck or proximal neck assembly of the balloon of the first medical device.
[Aspect 24]
24. The method of aspect 23, wherein the proximal neck of the balloon of the first medical device is the second portion of the mechanical latch.
[Aspect 25]
25. The method of aspect 23 or 24, wherein the two portions of the mechanical latch are engaged or operably coupled when the second catheter of the first medical device passes through the mechanical latch.
[Aspect 26]
26. The method of aspect 25, wherein the second catheter of the first medical device is removed from the mechanical latch to separate or operably separate the mechanical latch and the two parts of the mechanical latch.
[Aspect 27]
27. The method of aspect 26, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are pulled apart.
[Aspect 28]
The proximal neck or proximal neck assembly of the first catheter of the first medical device and the balloon of the first medical device are joined by an adhesive, glue, or solder, and the proximal neck of the balloon of the first medical device is joined. 21. The method of any one of aspects 1-20, wherein a portion of the proximal neck or proximal neck assembly is electrolytically eroded.
[Aspect 29]
30. According to aspect 28, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are pulled apart after erosion of a portion of the proximal neck or proximal neck assembly of the balloon of the first medical device. the method of.
[Aspect 30]
The first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device are joined by an adhesive, glue, or solder, and the first catheter of the first medical device. the distal portion of the catheter, the proximal neck or portion of the proximal neck assembly of the balloon of the first medical device, or the distal portion of the first catheter of the first medical device and the balloon of the first medical device; 21. The method of any one of aspects 1-20, wherein a portion of the bond between the proximal neck or proximal neck assembly melts upon heating.
[Aspect 31]
a distal portion of a first catheter of a first medical device, a proximal neck or proximal neck assembly portion of a balloon of a first medical device, or a distal portion of a first catheter of a first medical device and After melting of a portion of the bond between the proximal neck or proximal neck assembly of the balloon of the first medical device, the first catheter of the first medical device and the expanded balloon of the first medical device are pulled apart. 31. The method of claim 30. The first medical device.
[Aspect 32]
The first elongated body or expandable body of the second medical device is flexible, the second elongated body of the second medical device is flexible, or the 32. The method of any one of aspects 1-31, wherein the first elongate body and the second elongate body are flexible.
[Aspect 33]
the first catheter of the first medical device is flexible, the second catheter is flexible, the third catheter of the first medical device is flexible, or 33. The method of any one of aspects 1-32, wherein the first catheter and the second catheter of the first medical device are flexible.
[Aspect 34]
34. The method of any one of aspects 1-33, wherein the balloon of the first medical device is removable.
[Aspect 35]
35. The method of any one of aspects 1-34, wherein the balloon of the first medical device is deflated or compressed prior to expansion.
[Aspect 36]
36. The method of any one of aspects 1-35, wherein the fluid used to inflate the balloon of the first medical device is water, saline, a fluoroscopic contrast agent, or a combination thereof.
[Aspect 37]
A solution containing a fluoroscopic contrast agent through the second catheter of the first medical device and into the hub of the second catheter of the first medical device and prior to expansion of the balloon of the first medical device. 37. The method of any one of aspects 1-36, wherein the injection is performed under fluoroscopy into the lumen of the aortic chamber or heart chamber adjacent to the distal tip of the second catheter of the first medical device.
[Aspect 38]
a solution containing a fluoroscopic contrast agent through the second catheter of the first medical device and into the hub of the second catheter of the first medical device and after expansion of the balloon of the first medical device; but prior to separation of the inflated balloon of the first medical device and the first catheter of the first medical device, the aortic chamber or heart adjacent to the distal tip of the second catheter of the first medical device. 38. The method of any one of aspects 1-37, wherein the injection is performed under fluoroscopy into the lumen of the cavity.
[Aspect 39]
A solution containing a fluoroscopic contrast agent is passed through the second catheter of the first medical device, into the hub of the second catheter of the first medical device, and into the expanded balloon and the first medical device. Injection under fluoroscopy into the lumen of the aortic chamber or heart chamber adjacent to the distal tip of the second catheter of the first medical device after isolation of the first catheter of one medical device, aspects 1-38 A method according to any one of
[Aspect 40]
40. The method of any one of aspects 1-39, further comprising providing a first medical device and one or more second medical devices.

Aspects and embodiments relating to methods of treatment of biological conduits as disclosed herein:
[Aspect 1]
(a) determining the diameter and length of the segment of the biological conduit to be treated, and when the balloon of the first medical device is expanded, the expanded diameter is greater than or equal to the diameter of the selected segment of the biological conduit and the balloon selecting a first medical device comprising a balloon having an expanded length such that it can occupy at least a portion of the lumen of the conduit;
(b) positioning the balloon of the first medical device within the lumen of the biological conduit;
(c) delivering a fluid medium through the first lumen and into the interior volume of the balloon of the first medical device such that the expanded balloon fills a portion of the lumen of the biological conduit and the walls of the biological conduit; contacting at least a portion to assume an expanded configuration;

(d) maintaining the position of the expanded balloon of the first medical device while the distal tip of the second catheter of the first medical device is positioned in or within the central void of the expanded balloon of the first medical device; pulling back the second catheter of the first medical device until it is within the volume;
(e) from the proximal end of the second catheter of the first medical device, through the lumen of the second catheter of the first medical device, to the central void or interior volume of the expanded balloon of the first medical device; delivering within the first elongated or expandable body of the second medical device;
(f) separating the first elongated body or expandable body of the second medical device from the second elongated body of the second medical device and the first elongated body or expandable body of the second medical device; removing the second elongated body from the patient while leaving a possible body within the patient;
(g) steps (e) and ( repeating f);
(h) separating the expanded balloon of the first medical device from the first catheter of the first medical device; removing the first and second catheters of the first medical device from the patient while leaving the elongated body or first expandable body of the patient within the patient;
a first medical device comprising:
(i) (i-1) a distal region, generally a proximal region opposite said distal region, an intermediate region transitioning from said distal region to said proximal region, between proximal and distal regions; a first axis extending proximally-distally between and a second axis perpendicular to the first axis;
(i-2) a wall having an outer surface and an inner surface, the inner surface defining a central void or interior volume, extending generally continuously from the proximal region through the intermediate region to the distal region;
(i-3) allow passage of fluid from the first catheter into the central void or interior volume of the balloon and allow passage of a portion of the second catheter into the central void or interior volume of the balloon; an opening in the wall in the proximal region that allows
(i-4) an opening in the wall of the distal region that allows passage of a portion of the second catheter into the central void or interior volume of the balloon;
(i-5) a proximal neck or proximal neck assembly; and
(i-6) a pleated and folded balloon configured for permanent implantation within a human patient comprising a distal neck or distal neck assembly;
(ii) a first lumen for allowing passage of fluid from the proximal end of the first catheter to the distal end of the first catheter and into the central void or interior volume of the balloon; define,
(ii-1) a proximal end including a proximal hub; and
(ii-2) a first catheter comprising a distal portion operably coupled or joined to the proximal neck or proximal neck assembly of the balloon;
(iii) defining a second lumen configured to receive at least one of a guidewire, an elongated body, an expandable body, or a coagulation fluid;
(iii-1) a proximal end including a proximal hub;
(iii-2) a proximal portion passing through the proximal hub of the first catheter;
(iii-3) an intermediate portion passing through the lumen of the first catheter;
(iii-4) a distal portion extending distally to the distal end of the first catheter;
(iii-5) a distal portion passing through the proximal neck or proximal neck assembly of the balloon;
(iii-6) a distal portion passing through the central void or interior volume of the balloon;
(iii-7) a distal portion that engages or passes through a distal neck or distal neck assembly within the balloon; and
(iii-8); a second catheter comprising an open distal end;
including
(iv) expanding the balloon by passage of fluid through the first catheter and into the central void or interior volume of the balloon;
After inflation of the balloon, the second catheter can be moved forward or backward while the inflated balloon remains fixed in place;
One or more of the first elongate body, the expandable body, the clotting fluid, the solution containing the drug or therapeutic agent, or the embolic particles after expansion of the balloon, including before or after advancing the tip of the second catheter. can be placed through the lumen of the second catheter into the biological space adjacent to the balloon;
After expansion of the balloon, the second catheter can be pulled back until the distal tip of the second catheter is positioned within the central void or interior volume of the balloon, and the one or more first elongate bodies, expanded A possible body, or coagulation fluid, can be passed through the lumen of the second catheter and disposed within the central void or interior volume of the balloon,
the first catheter can be separated from the inflated balloon;
the first and second catheters can be removed from the patient while leaving the balloon and one or more of the first elongate bodies, expandable bodies, or coagulation fluid within the patient;
the second medical device
(i) a distal portion comprising a first elongated or expandable body;
(ii) a proximal portion comprising a second elongated body or delivery system;
including
at least the first elongate body or expandable body of the second medical device after placement of the first elongate body or expandable body of the second medical device within the expanded balloon of the first medical device; contacting at least a portion of the wall of the expanded balloon of the first medical device;
After placement of the first elongated or expandable body of the second medical device within the central void or interior volume of the inflated balloon of the first medical device, but the first the second medical device can be removed from the patient prior to separation of the elongate body or expandable body and the second elongate body of the second medical device;
the first elongated body or expandable body can be separated from the second elongated body;
After separating the first elongate body or expandable body from the second elongate body, removing the second elongate body from the patient while leaving the first elongate body or expandable body within the patient. 1. A method of reducing fluid flow in a biological conduit of a human patient using two or more medical devices.
[Aspect 2]
fluoroscopic contrast agent, drug or infusing a solution containing a therapeutic agent, a clotting fluid, or a combination thereof through the lumen of the second catheter of the first medical device and into the biological conduit adjacent to the inflated balloon of the first medical device; A method according to aspect 1.
[Aspect 3]
A fluoroscopic contrast agent, a drug, a therapeutic agent, a coagulation fluid, or a combination thereof, through the lumen of the shaft of the second catheter of the first medical device and into the body adjacent to the expanded balloon of the first medical device. A method according to aspect 2, wherein a syringe or other suitable delivery system is used to inject into the conduit.
[Aspect 4]
fluoroscopic contrast agent, drug, therapeutic agent, coagulation fluid, or the like through the shaft lumen of the second catheter of the first medical device and into the biological conduit adjacent to the inflated balloon of the first medical device. 4. The method of aspect 2 or 3, wherein the second catheter of the first medical device is advanced within the biological conduit while maintaining the position of the balloon of the first medical device prior to injecting the combination of.
[Aspect 5]
the second catheter of the first medical device from the proximal end of the second catheter of the first medical device prior to separating the inflated balloon of the first medical device from the first catheter of the first medical device; 3. The method of aspect 1 or 2, wherein the coagulation fluid is infused through the lumen of the catheter of and into the central void or interior volume of the inflated balloon of the first medical device.
[Aspect 6]
After being positioned within the central void or interior volume of the expanded balloon, the first elongated or expandable body of the second medical device exerts a force on the wall of the expanded balloon of the first medical device, Aspect 1 6. The method according to any one of 1 to 5.
[Aspect 7]
7. The method of aspect 6, wherein the force on the walls of the expanded balloon of the first medical device is outward.
[Aspect 8]
8. The method of any one of aspects 1-7, wherein the maximum or tertiary diameter of the second medical device is equal to the maximum diameter of the inflated balloon.
[Aspect 9]
from a value in which the maximum diameter or tertiary diameter of the first elongate body or expandable body of the second medical device is equal to the maximum diameter of the expanded balloon of the first medical device to the expanded balloon of the first medical device A method according to any one of aspects 1 to 7, which ranges up to a value that is 50% greater than the maximum diameter of the .
[Aspect 10]
the maximum overall or tertiary diameter of the first elongated or expandable body of the second medical device is 1, 2, 3, 4, 5, 6 greater than the maximum diameter of the expanded balloon of the first medical device , 7, 8, 9, or 10 mm.
[Aspect 11]
11. Any of aspects 1-10, wherein the volume of the one or more first elongated or expandable bodies of the second medical device fills 5-75% of the volume of the central void or interior volume of the expanded balloon. 1. The method according to item 1.
[Aspect 12]
the volume of the first elongate body or expandable body of the second medical device is 5, 6, 7, 8, 9, 10, 11, 12, 13 the volume of the central void or interior volume of the expanded balloon; 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 13. The method of any one of aspects 1-12, wherein the method is 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, or 75% full.
[Aspect 13]
The expanded balloon covers at least 100%, 90%, 80%, 70, 60%, 50%, 40%, 30%, 20%, 10%, or 5% of the luminal surface area of the selected biological conduit. 13. The method of any one of aspects 1-12, wherein the method is configured to contact the
[Aspect 14]
The expanded balloon is at least 100%, 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10%, or 5% of the volume of the lumen of the selected segment of the biological conduit. 15. The method of any one of aspects 1-14, wherein the method is configured to fill %.
[Aspect 15]
A distal portion of the second catheter of the first medical device includes a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy reveals that the second catheter of the first medical device 15. Any of aspects 1-14, used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal portion of the balloon of the first medical device when moving. 1. The method according to item 1.
[Aspect 16]
A distal portion of the balloon of the first medical device includes a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy reveals that the second catheter of the first medical device is displaced. 16., according to any one of aspects 1 to 15, used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal portion of the balloon of the first catheter. Method.
[Aspect 17]
At least a portion of the distal telescoping structure of the first medical device includes a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy reveals that the second catheter of the first medical device is 17. Any of aspects 1-16, used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal telescoping structure of the first medical device when moving. 1. The method according to item 1.
[Aspect 18]
At least a portion of the first elongated or expandable body of the second medical device is formed from a material that is radiopaque and is clearly visible under fluoroscopy, and fluoroscopy is performed on the second medical device. 18. The method of any one of aspects 1-17, wherein the method is used to monitor placement and position of the first elongate body or expandable body of the.
[Aspect 19]
The second catheter of the first medical device includes one, two, or more radiopaque portions, rings or markers, and fluoroscopy is performed on the first catheter of the second medical device. 19. The method of any one of aspects 1-18, wherein the method is used to monitor the position of the second catheter of the first medical device relative to the position of the elongate body or expandable body.
[Aspect 20]
A distal portion of the first catheter of the first medical device includes a radiopaque marker that is clearly visible under fluoroscopy, and fluoroscopy is used to detect the first medical device from the first catheter of the first medical device. 20. The method of any one of aspects 1-19, wherein the method is used to monitor the separation of an inflated balloon of a device.
[Aspect 21]
A proximal portion of the balloon of the first medical device includes radiopaque markers that are clearly visible under fluoroscopy, and fluoroscopy is used to dilate the first medical device from the first catheter of the first medical device. 21. The method of any one of aspects 1-20, wherein the method is used to monitor the detachment of a balloon.
[Aspect 22]
22. The method of any one of aspects 15-21, wherein the radiopaque portion, ring, or marker comprises platinum, iridium, gold, tungsten, or combinations thereof.
[Aspect 23]
The second catheter of the first medical device and the distal neck or distal neck assembly of the balloon of the first medical device are coupled by a friction fit, and the second catheter of the first medical device and the first 23. The method of any one of aspects 1-22, wherein the expanded balloon of the medical device is separated by applying axial tension to the bond.
[Aspect 24]
24. The method of aspect 23, wherein the second catheter of the first medical device and the distal neck or distal neck assembly of the balloon of the first medical device are joined by an elastomeric valve.
[Aspect 25]
the elastomeric valve acts to reduce the flow of biological fluid through the central void or interior volume of the expanded balloon of the first medical device after removal of the second catheter of the first medical device from the patient; 25. The method of aspect 24.
[Aspect 26]
The first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device are coupled by a friction fit, and the first catheter of the first medical device and the first 26. The method of any one of aspects 1-25, wherein the expanded balloon of the medical device is separated by applying axial tension to the bond.
[Aspect 27]
27. The method of aspect 26, wherein the proximal neck or proximal neck assembly of the first catheter of the first medical device and the balloon of the first medical device are joined by an elastomeric tubular segment.
[Aspect 28]
A first catheter of the first medical device and a balloon of the first medical device are coupled by a mechanical latch, a portion of the mechanical latch is joined to the distal end of the first catheter, and a first catheter of the mechanical latch. 26. The method of any one of aspects 1-25, wherein two portions are joined to the proximal neck or proximal neck assembly of the balloon of the first medical device.
[Aspect 29]
29. The method of aspect 28, wherein the proximal neck of the balloon of the first medical device is the second portion of the mechanical latch.
[Aspect 30]
30. The method of aspect 28 or 29, wherein the two portions of the mechanical latch are engaged or operably coupled when the second catheter of the first medical device passes through the mechanical latch.
[Aspect 31]
31. The method of aspect 30, wherein the second catheter of the first medical device is removed from the mechanical latch to separate or operably separate the mechanical latch and the two parts of the mechanical latch.
[Aspect 32]
32. The method of aspect 31, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are separated.
[Aspect 33]
The proximal neck or proximal neck assembly of the first catheter of the first medical device and the balloon of the first medical device are joined by an adhesive, glue, or solder, and the proximal neck of the balloon of the first medical device is joined. 26. The method of any one of aspects 1-25, wherein a portion of the proximal neck or proximal neck assembly is electrolytically eroded.
[Aspect 34]
34. According to aspect 33, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are separated after erosion of a portion of the proximal neck or proximal neck assembly of the balloon of the first medical device. the method of.
[Aspect 35]
The first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device are joined by an adhesive, glue, or solder, and the first catheter of the first medical device. the distal portion of the catheter, the proximal neck or portion of the proximal neck assembly of the balloon of the first medical device, or the distal portion of the first catheter of the first medical device and the balloon of the first medical device; 26. The method of any one of aspects 1-25, wherein a portion of the bond between the proximal neck or proximal neck assembly melts upon heating.
[Aspect 36]
a distal portion of a first catheter of a first medical device, a proximal neck or proximal neck assembly portion of a balloon of a first medical device, or a distal portion of a first catheter of a first medical device and After melting of a portion of the bond between the proximal neck or proximal neck assembly of the balloon of the first medical device, the first catheter of the first medical device and the expanded balloon of the first medical device are pulled apart. 36. The method of aspect 35. The first medical device.
[Aspect 37]
The first elongated body or expandable body of the second medical device is flexible, the second elongated body of the second medical device is flexible, or the 37. The method of any one of aspects 1-36, wherein the first elongate body and the second elongate body are flexible.
[Aspect 38]
The first catheter of the first medical device is flexible and the second catheter of the first medical device is flexible, or the first catheter and the first catheter of the first medical device are flexible. 38. The method of any one of aspects 1-37, wherein the catheter of 2 is flexible.
[Aspect 39]
39. The method of any one of aspects 1-38, wherein the balloon of the first medical device is removable.
[Aspect 40]
40. The method of any one of aspects 1-39, wherein the balloon of the first medical device is deflated or compressed prior to expansion.
[Aspect 41]
41. The method of any one of aspects 1-40, wherein the fluid used to inflate the balloon of the first medical device is water, saline, a fluoroscopic contrast agent, or a combination thereof.
[Aspect 42]
A solution containing a fluoroscopic contrast agent through the second catheter of the first medical device and into the hub of the second catheter of the first medical device and prior to expansion of the balloon of the first medical device. 42. The method of any one of aspects 1-41, wherein the second catheter of the first medical device is injected under fluoroscopy into the lumen of the biological conduit adjacent the distal tip of the second catheter.
[Aspect 43]
a solution containing a fluoroscopic contrast agent through the second catheter of the first medical device and into the hub of the second catheter of the first medical device and after balloon expansion of the first medical device. within the lumen of the biological conduit adjacent the distal tip of the second catheter of the first medical device prior to separation of the expanded balloon of the first medical device and the first catheter of the first medical device 43. The method of any one of aspects 1-42, wherein the injection is performed during fluoroscopy.
[Aspect 44]
A solution containing a fluoroscopic contrast agent is passed through the second catheter of the first medical device, into the hub of the second catheter of the first medical device, and into the expanded balloon and the first medical device. 44. Any of aspects 1-43, wherein after isolation of the first catheter of one medical device, injection under fluoroscopy into the lumen of the biological conduit adjacent the distal tip of the second catheter of the first medical device. 1. The method according to item 1.
[Aspect 45]
45. The method of any one of aspects 1-44, further comprising providing a first medical device and one or more second medical devices.

Aspects and embodiments relating to methods of treating a biological space as disclosed herein:
[Aspect 1]
(a) determining the diameter and length of the biological space to be treated, and when the balloon of the first medical device is expanded, the expanded diameter is greater than or equal to the diameter of the selected biological space, and the balloon selecting a first medical device comprising a balloon having an expanded length such that it can occupy at least a portion of the medical space;
(b) positioning the balloon of the first medical device within the biological space;
(c) delivering a fluid medium through the first lumen into the central void or interior volume of the balloon of the first medical device such that the expanded balloon fills a portion of the biological space and assuming an extended configuration contacting at least a portion of the wall of the target space;
(d) maintaining the position of the expanded balloon of the first medical device while the distal tip of the second catheter of the first medical device is positioned in or within the central void of the expanded balloon of the first medical device; pulling back the second catheter of the first medical device until it is within the volume;
(e) from the proximal end of the second catheter of the first medical device, through the lumen of the second catheter of the first medical device, to the central void or interior volume of the expanded balloon of the first medical device; delivering within the first elongated or expandable body of the second medical device;
(f) separating the first elongated body or expandable body of the second medical device from the second elongated body of the second medical device and the first elongated body or expandable body of the second medical device; removing the second elongated body from the patient while leaving a possible body within the patient;
(g) steps (e) and ( repeating f);
(h) separating the expanded balloon of the first medical device from the first catheter of the first medical device; removing the first and second catheters of the first medical device from the patient while leaving the elongated body or first expandable body of the patient within the patient;
a first medical device comprising:
(i) (i-1) a distal region, generally a proximal region opposite said distal region, an intermediate region transitioning from said distal region to said proximal region, between proximal and distal regions; a first axis extending proximally-distally between and a second axis perpendicular to the first axis;
(i-2) a wall having an outer surface and an inner surface, the inner surface defining a central void or interior volume, extending generally continuously from the proximal region through the intermediate region to the distal region;
(i-3) allow passage of fluid from the first catheter into the central void or interior volume of the balloon and allow passage of a portion of the second catheter into the central void or interior volume of the balloon; an opening in the wall in the proximal region that allows
(i-4) an opening in the wall of the distal region that allows passage of a portion of the second catheter into the central void or interior volume of the balloon;
(i-5) a proximal neck or proximal neck assembly; and
(i-6) a pleated and folded balloon configured for permanent implantation within a human patient comprising a distal neck or distal neck assembly;
(ii) a first lumen for allowing passage of fluid from the proximal end of the first catheter to the distal end of the first catheter and into the central void or interior volume of the balloon; define,
(ii-1) a proximal end including a proximal hub; and
(ii-2) a first catheter comprising a distal portion operably coupled or joined to the proximal neck or proximal neck assembly of the balloon;
(iii) defining a second lumen configured to receive at least one of a guidewire, an elongated body, an expandable body, or a coagulation fluid;
(iii-1) a proximal end including a proximal hub;
(iii-2) a proximal portion passing through the proximal hub of the first catheter;
(iii-3) an intermediate portion passing through the lumen of the first catheter;
(iii-4) a distal portion extending distally to the distal end of the first catheter;
(iii-5) a distal portion passing through the proximal neck or proximal neck assembly of the balloon;
(iii-6) a distal portion passing through the central void or interior volume of the balloon;
(iii-7) a distal portion that engages or passes through a distal neck or distal neck assembly within the balloon; and
(iii-8); a second catheter comprising an open distal end;
including
(iv) expanding the balloon by passage of fluid through the first catheter and into the central void or interior volume of the balloon;
After inflation of the balloon, the second catheter can be moved forward or backward while the inflated balloon remains fixed in place;
One or more of the first elongate body, the expandable body, the clotting fluid, the solution containing the drug or therapeutic agent, or the embolic particles after expansion of the balloon, including before or after advancing the tip of the second catheter. can be placed through the lumen of the second catheter into the biological space adjacent to the balloon;
After expansion of the balloon, the second catheter can be pulled back until the distal tip of the second catheter is positioned within the central void or interior volume of the balloon, and the one or more first elongate bodies, expanded A possible body, or coagulation fluid, can be passed through the lumen of the second catheter and disposed within the central void or interior volume of the balloon,
the first catheter can be separated from the inflated balloon;
the first and second catheters can be removed from the patient while leaving the balloon and one or more of the first elongate bodies, expandable bodies, or coagulation fluid within the patient;
the second medical device
(i) a distal portion comprising a first elongated or expandable body;
(ii) a proximal portion comprising a second elongated body or delivery system;
including
at least the first elongate body or expandable body of the second medical device after placement of the first elongate body or expandable body of the second medical device within the expanded balloon of the first medical device; contacting at least a portion of the wall of the expanded balloon of the first medical device;
After placement of the first elongated or expandable body of the second medical device within the central void or interior volume of the inflated balloon of the first medical device, but the first the second medical device can be removed from the patient prior to separation of the elongate body or expandable body and the second elongate body of the second medical device;
the first elongated body or expandable body can be separated from the second elongated body;
After separating the first elongate body or expandable body from the second elongate body, removing the second elongate body from the patient while leaving the first elongate body or expandable body within the patient. A method of reducing biological fluid flow in a biological space of a human patient using two or more medical devices.
[Aspect 2]
fluoroscopic contrast agent, drug or Injecting a solution containing a therapeutic agent, a coagulation fluid, or a combination thereof through the lumen of the second catheter of the first medical device and into the biological space adjacent to the expanded balloon of the first medical device. The method according to aspect 1.
[Aspect 3]
A fluoroscopic contrast agent, drug, therapeutic agent, clotting fluid, or a combination thereof, through the lumen of the shaft of the second catheter of the first medical device and into the organism adjacent to the expanded balloon of the first medical device. 3. The method of aspect 2, wherein a syringe or other suitable delivery system is used to inject into the biomedical space.
[Aspect 4]
through the shaft lumen of the second catheter of the first medical device and into the biological space adjacent to the expanded balloon of the first medical device, a fluoroscopic contrast agent, a drug, a therapeutic agent, a coagulation fluid, Aspect 2 or 3, wherein the second catheter of the first medical device is advanced within the biological space while maintaining the position of the balloon of the first medical device prior to injecting or a combination thereof. Method.
[Aspect 5]
the second catheter of the first medical device from the proximal end of the second catheter of the first medical device prior to separating the inflated balloon of the first medical device from the first catheter of the first medical device; 3. The method of aspect 1 or 2, wherein the coagulation fluid is infused through the lumen of the catheter of and into the central void or interior volume of the inflated balloon of the first medical device.
[Aspect 6]
After being positioned within the central void or interior volume of the expanded balloon, the first elongated or expandable body of the second medical device exerts a force on the wall of the expanded balloon of the first medical device, Aspect 1 6. The method according to any one of 1 to 5.
[Aspect 7]
7. The method of aspect 6, wherein the force on the walls of the expanded balloon of the first medical device is outward.
[Aspect 8]
8. The method of any one of aspects 1-7, wherein the maximum or tertiary diameter of the second medical device is equal to the maximum diameter of the inflated balloon.
[Aspect 9]
from a value in which the maximum diameter or tertiary diameter of the first elongate body or expandable body of the second medical device is equal to the maximum diameter of the expanded balloon of the first medical device to the expanded balloon of the first medical device A method according to any one of aspects 1 to 7, which ranges up to a value that is 50% greater than the maximum diameter of the .
[Aspect 10]
the maximum overall or tertiary diameter of the first elongated or expandable body of the second medical device is 1, 2, 3, 4, 5, 6 greater than the maximum diameter of the expanded balloon of the first medical device , 7, 8, 9, or 10 mm.
[Aspect 11]
11. Any of aspects 1-10, wherein the volume of the one or more first elongated or expandable bodies of the second medical device fills 5-75% of the volume of the central void or interior volume of the expanded balloon. 1. The method according to item 1.
[Aspect 12]
the volume of the first elongate body or expandable body of the second medical device is 5, 6, 7, 8, 9, 10, 11, 12, 13 the volume of the central void or interior volume of the expanded balloon; 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 13. The method of any one of aspects 1-12, wherein the method is 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, or 75% full.
[Aspect 13]
The expanded balloon expands at least 100%, 90%, 80%, 70, 60%, 50%, 40%, 30%, 20%, 10%, or 13. The method of any one of aspects 1-12, configured to contact 5%.
[Aspect 14]
The expanded balloon comprises at least 100%, 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10% of the lumen volume of the selected segment of the biological space; or 5% loading.
[Aspect 15]
A distal portion of the second catheter of the first medical device includes a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy reveals that the second catheter of the first medical device 15. Any of aspects 1-14, used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal portion of the balloon of the first medical device when moving. 1. The method according to item 1.
[Aspect 16]
A distal portion of the balloon of the first medical device includes a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy reveals that the second catheter of the first medical device is displaced. 16., according to any one of aspects 1 to 15, used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal portion of the balloon of the first catheter. Method.
[Aspect 17]
At least a portion of the distal telescoping structure of the first medical device includes a radiopaque portion, ring or marker that is clearly visible under fluoroscopy, and fluoroscopy reveals that the second catheter of the first medical device is 17. Any of aspects 1-16, used to monitor the position of the distal portion of the second catheter of the first medical device relative to the position of the distal telescoping structure of the first medical device when moving. 1. The method according to item 1.
[Aspect 18]
At least a portion of the first elongated or expandable body of the second medical device is formed from a material that is radiopaque and is clearly visible under fluoroscopy, and fluoroscopy is performed on the second medical device. 18. The method of any one of aspects 1-17, wherein the method is used to monitor placement and position of the first elongate body or expandable body of the.
[Aspect 19]
The second catheter of the first medical device includes one, two, or more radiopaque portions, rings or markers, and fluoroscopy is performed on the first catheter of the second medical device. 19. The method of any one of aspects 1-18, wherein the method is used to monitor the position of the second catheter of the first medical device relative to the position of the elongate body or expandable body.
[Aspect 20]
A distal portion of the first catheter of the first medical device includes a radiopaque marker that is clearly visible under fluoroscopy, and fluoroscopy is used to detect the first medical device from the first catheter of the first medical device. 20. The method of any one of aspects 1-19, wherein the method is used to monitor the separation of an inflated balloon of a device.
[Aspect 21]
A proximal portion of the balloon of the first medical device includes radiopaque markers that are clearly visible under fluoroscopy, and fluoroscopy is used to dilate the first medical device from the first catheter of the first medical device. 21. The method of any one of aspects 1-20, wherein the method is used to monitor the detachment of a balloon.
[Aspect 22]
22. The method of any one of aspects 15-21, wherein the radiopaque portion, ring, or marker comprises platinum, iridium, gold, tungsten, or combinations thereof.
[Aspect 23]
The second catheter of the first medical device and the distal neck or distal neck assembly of the balloon of the first medical device are coupled by a friction fit, and the second catheter of the first medical device and the first 23. The method of any one of aspects 1-22, wherein the expanded balloon of the medical device is separated by applying axial tension to the bond.
[Aspect 24]
24. The method of aspect 23, wherein the second catheter of the first medical device and the distal neck or distal neck assembly of the balloon of the first medical device are joined by an elastomeric valve.
[Aspect 25]
the elastomeric valve acts to reduce the flow of biological fluid through the central void or interior volume of the expanded balloon of the first medical device after removal of the second catheter of the first medical device from the patient; 25. The method of aspect 24.
[Aspect 26]
The first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device are coupled by a friction fit, and the first catheter of the first medical device and the first 26. The method of any one of aspects 1-25, wherein the expanded balloon of the medical device is separated by applying axial tension to the bond.
[Aspect 27]
27. The method of aspect 26, wherein the proximal neck or proximal neck assembly of the first catheter of the first medical device and the balloon of the first medical device are joined by an elastomeric tubular segment.
[Aspect 28]
A first catheter of the first medical device and a balloon of the first medical device are coupled by a mechanical latch, a portion of the mechanical latch is joined to the distal end of the first catheter, and a first catheter of the mechanical latch. 26. The method of any one of aspects 1-25, wherein two portions are joined to the proximal neck or proximal neck assembly of the balloon of the first medical device.
[Aspect 29]
29. The method of aspect 28, wherein the proximal neck of the balloon of the first medical device is the second portion of the mechanical latch.
[Aspect 30]
30. The method of aspect 28 or 29, wherein the two portions of the mechanical latch are engaged or operably coupled when the second catheter of the first medical device passes through the mechanical latch.
[Aspect 31]
31. The method of aspect 30, wherein the second catheter of the first medical device is removed from the mechanical latch to separate or operably separate the mechanical latch and the two parts of the mechanical latch.
[Aspect 32]
32. The method of aspect 31, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are separated.
[Aspect 33]
The proximal neck or proximal neck assembly of the first catheter of the first medical device and the balloon of the first medical device are joined by an adhesive, glue, or solder, and the proximal neck of the balloon of the first medical device is joined. 26. The method of any one of aspects 1-25, wherein a portion of the proximal neck or proximal neck assembly is electrolytically eroded.
[Aspect 34]
34. According to aspect 33, wherein the first catheter of the first medical device and the expanded balloon of the first medical device are separated after erosion of a portion of the proximal neck or proximal neck assembly of the balloon of the first medical device. the method of.
[Aspect 35]
The first catheter of the first medical device and the proximal neck or proximal neck assembly of the balloon of the first medical device are joined by an adhesive, glue, or solder, and the first catheter of the first medical device. the distal portion of the catheter, the proximal neck or portion of the proximal neck assembly of the balloon of the first medical device, or the distal portion of the first catheter of the first medical device and the balloon of the first medical device; 26. The method of any one of aspects 1-25, wherein a portion of the bond between the proximal neck or proximal neck assembly melts upon heating.
[Aspect 36]
a distal portion of a first catheter of a first medical device, a proximal neck or proximal neck assembly portion of a balloon of a first medical device, or a distal portion of a first catheter of a first medical device and After melting of a portion of the bond between the proximal neck or proximal neck assembly of the balloon of the first medical device, the first catheter of the first medical device and the expanded balloon of the first medical device are pulled apart. 36. The method of aspect 35. The first medical device.
[Aspect 37]
The first elongated body or expandable body of the second medical device is flexible, the second elongated body of the second medical device is flexible, or the 37. The method of any one of aspects 1-36, wherein the first elongate body and the second elongate body are flexible.
[Aspect 38]
The first catheter of the first medical device is flexible and the second catheter of the first medical device is flexible, or the first catheter and the first catheter of the first medical device are flexible. 38. The method of any one of aspects 1-37, wherein the catheter of 2 is flexible.
[Aspect 39]
39. The method of any one of aspects 1-38, wherein the balloon of the first medical device is removable.
[Aspect 40]
40. The method of any one of aspects 1-39, wherein the balloon of the first medical device is deflated or compressed prior to expansion.
[Aspect 41]
41. The method of any one of aspects 1-40, wherein the fluid used to inflate the balloon of the first medical device is water, saline, a fluoroscopic contrast agent, or a combination thereof.
[Aspect 42]
A solution containing a fluoroscopic contrast agent through the second catheter of the first medical device and into the hub of the second catheter of the first medical device and prior to expansion of the balloon of the first medical device. 42. The method of any one of aspects 1-41, wherein the second catheter of the first medical device is injected under fluoroscopy into the biological space adjacent to the distal tip of the second catheter.
[Aspect 43]
a solution containing a fluoroscopic contrast agent through the second catheter of the first medical device and into the hub of the second catheter of the first medical device and after balloon expansion of the first medical device. within the biological space adjacent the distal tip of the second catheter of the first medical device prior to separation of the expanded balloon of the first medical device and the first catheter of the first medical device 43. The method of any one of aspects 1-42, wherein the injection is performed during fluoroscopy.
[Aspect 44]
A solution containing a fluoroscopic contrast agent is passed through the second catheter of the first medical device, into the hub of the second catheter of the first medical device, and into the expanded balloon and the first medical device. 44. Any of aspects 1-43, wherein after isolation of the first catheter of one medical device, injection under fluoroscopy into the biological space adjacent to the distal tip of the second catheter of the first medical device 1. The method according to item 1.
[Aspect 45]
45. The method of any one of aspects 1-44, further comprising providing a first medical device and one or more second medical devices.

It is also understood that the apparatus and methods of the present disclosure can be embodied in various embodiments, only a few of which have been shown and described. The disclosure herein may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects as illustrative and not restrictive, and the scope of the invention is therefore determined by the foregoing description and not by the appended claims. is indicated by All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims (38)

a distal region, generally a proximal region opposite the distal region, an intermediate region transitioning from the distal region to the proximal region, a proximal-distal region between the proximal region and the distal region; a first axis extending in position and a second axis perpendicular to the first axis;
a wall having an outer surface and an inner surface and extending generally continuously from said proximal region through said intermediate region to said distal region;
a central void defined by said inner surface of said wall;
a proximal opening in the wall at the proximal region that allows passage of fluid into the central void of the balloon; and a distal opening in the wall at the distal region; the balloon configured for permanent implantation within the space;
a first proximal end coupled to the first proximal hub;
a first catheter comprising: a first distal end; and a first distal portion operably connected to the proximal opening of the balloon;
a second proximal end coupled to a second proximal hub;
a second proximal portion passing through the first proximal hub of the first catheter;
a second catheter comprising: a second distal portion passing through the proximal opening, the central void, and the distal opening of the balloon; and an open second distal end;
a removable assembly for joining the balloon to the first catheter;
A medical device for placement in a biological space comprising
The first catheter, together with the second catheter, allows fluid to pass from the first proximal end to the first distal end of the first catheter and into the central void of the balloon. defining a first lumen that allows
said passage of said liquid through said first lumen into said central void causes said balloon to expand from a compressed configuration to an expanded configuration;
the second catheter defines a second lumen configured to receive one or more second medical devices including an assembly of braided metal wires or an assembly of braided metal wires;
After inflation of the balloon, the second catheter is operated to move forward or backward while the first catheter and the balloon remain in a fixed position;
After expansion of the balloon, at least one of the one or more second medical devices permits passage through the second lumen of the second catheter into the biological space adjacent to the balloon. operable to move the second catheter forward until the second distal end of the second catheter is positioned within the biological space,
such that after expansion of the balloon, at least one of the one or more second medical devices allows passage of the second catheter through the second lumen into the central void of the balloon. operable to move the second catheter rearwardly until the second distal end of the second catheter is positioned within the central void of the balloon;
After expansion of the balloon and after all or a portion of the one or more second medical devices have passed through the second lumen of the second catheter and into the central void of the balloon, the first are operable to detach from the balloon, and the first catheter and the second catheter remain in the biological space in whole or in part on the balloon and the one or more medical devices. while operating to be removed from the biological space;
medical device. 2. The medical device of claim 1, wherein the wall of the balloon comprises a monolayer of polymer. 3. The medical device of claim 2, wherein the monolayer of polymer comprises a continuous layer of polymer. 3. The medical device of claim 2, wherein the monolayer of polymer comprises a discontinuous layer of polymer. The medical device of any one of claims 1-4, wherein the balloon further comprises a proximal neck and a distal neck. 2. The medical device of claim 1, wherein at least a portion of the balloon wall comprises two or more polymer layers. 3. The medical device of claim 1, wherein the balloon wall comprises a single layer of metal. 8. The medical device of claim 7, wherein the monolayer of metal comprises a continuous layer of metal. 8. The medical device of claim 7, wherein the monolayer of metal comprises a discontinuous layer of metal. The medical device of any one of claims 7-9, wherein the monolayer of metal comprises gold or an alloy thereof. The medical device of any one of claims 7-9, wherein the metal monolayer comprises platinum or an alloy thereof. 2. The medical device of claim 1, wherein the wall of the balloon comprises one or more outer layers or coatings and one or more inner layers or coatings. 13. The medical device of claim 12, wherein the one or more outer layers or coatings and the one or more inner layers or coatings comprise one or more polymers. 2. The medical device of claim 1, wherein the wall of the balloon comprises an inner layer comprising metal and an outer layer or coating comprising a polymer. 15. The medical device of claim 14, wherein the polymer is a metal in which the inner layer comprising the metal is impermeable to the outer surface of the balloon. A medical device according to claim 14 or 15, wherein the outer layer or coating has a thickness of 0.1-100 μm. an expandable metal retention structure, wherein after the expandable metal retention structure and the balloon are expanded, a retention structure diameter of a portion of the expandable metal retention structure is greater than or equal to the diameter of the balloon; A medical device according to any one of claims 1-16. including a third catheter;
a third inner surface of the third catheter and a first outer surface of the first catheter are at least a portion of the first catheter, the second catheter, and the expandable metal retention structure; defining a third lumen configured to receive the
the third catheter
a third proximal end coupled to a third proximal hub; and said expandable until it passes over at least a portion of said expandable metal retention structure and said third catheter is withdrawn. a third distal end that retains the metal retention structure in a compressed retention shape;
including
18. The medical device of claim 17, wherein withdrawal of the third catheter expands the expandable metal retention structure from the compressed retention structure to an expanded retention structure. The medical device of any one of claims 1-18, wherein the first catheter can be separated from the balloon by pulling the first catheter and the balloon apart. The medical device of any one of claims 1-18, wherein the second catheter can be separated from the balloon by pulling the second catheter and balloon apart. 19. Any one of claims 1-18, wherein the first and second catheters can be separated from the balloon by pulling apart the assembly of the first and second catheters and the balloon. A medical device according to paragraph. combining a portion of the first distal end of the first catheter and a portion of the proximal neck of the balloon to form a mechanical attachment between the first catheter and the balloon; The target attachment is configured to engage when the second catheter passes through the attachment site of the mechanical attachment and disengage when the second catheter is removed from the attachment site of the mechanical attachment. 22. The medical device of any one of claims 1-21, configured to untangle. 2. The medical device of claim 1, wherein the second catheter can be separated from the balloon by pulling the second catheter and the balloon apart. withdrawing the shaft of the second catheter from within the lumen of the first removable assembly of the tubular male structure when the removable assembly changes from an engaged configuration to a disengaged configuration; 24. The medical device of claim 23, wherein the first assembly can be separated from the second assembly by pulling apart the first catheter and the balloon. a removable assembly for joining the balloon to the first catheter, the removable assembly coupled to a proximal neck of the balloon and the first distal end of the first catheter; a first tubular structure configured for friction fit with
The balloon is inflated within an artery, vein, left atrial appendage, aneurysm, biological conduit, or other blood-containing space or biological space and attached to at least a portion of the outer surface of the balloon or to the balloon. when a portion of the outer surface of the expandable metal retention structure contacts at least a portion of the wall of an artery, vein, left atrial appendage, aneurysm, biological conduit, or other blood-containing or biological space; , separating the first catheter from the proximal neck of the balloon and the first tubular structure by pulling apart the assembly of the first catheter and the proximal neck of the balloon and the first tubular structure; 19. The medical device of claim 17 or 18, which can be separated from the assembly of the a removable assembly for joining the balloon to the first catheter, the removable assembly coupled to a proximal neck of the balloon and the first distal end of the first catheter; a first tubular structure configured for friction fit with
The balloon is inflated within an artery, vein, left atrial appendage, aneurysm, biological conduit, or other blood-containing space or biological space and attached to at least a portion of the outer surface of the balloon or to the balloon. A portion of the outer retaining surface of the expandable metal retention structure contacts at least a portion of the wall of an artery, vein, left atrial appendage, aneurysm, biological conduit, or other blood-containing or biological space. Sometimes, the first catheter and the proximal neck of the balloon and the first assembly of the first tubular structure are pulled apart to move the first catheter to the proximal neck of the balloon and the first tubular structure. 19. The medical device of claim 17 or 18, which can be separated from the assembly of the a removable assembly for joining the balloon to the first catheter, the removable assembly coupled to the first distal end of the first catheter and a proximal neck of the balloon; a first tubular structure configured for friction fit with
The balloon is inflated within an artery, vein, left atrial appendage, aneurysm, biological conduit, or other blood-containing space or biological space and attached to at least a portion of the outer surface of the balloon or to the balloon. when a portion of the outer surface of the expandable metal retention structure contacts at least a portion of an artery, vein, left atrial appendage, aneurysm, biological conduit, or other blood-containing space or wall of the biological space; separating the removable assembly of the first catheter and first tubular structure from the proximal neck of the balloon by pulling apart the assembly of the first catheter and first tubular structure and the balloon; 19. The medical device of claim 17 or 18, capable of a removable assembly for joining the balloon to the second catheter;
said removable assembly comprising one or more elastomeric valves joined to a distal neck or distal neck assembly of said balloon;
the one or more elastomeric valves configured to friction fit with the second distal end of the second catheter;
The balloon is inflated within an artery, vein, left atrial appendage, aneurysm, biological conduit, or other blood-containing space or biological space and attached to at least a portion of the outer surface of the balloon or to the balloon. A portion of the outer retaining surface of the expandable metal retaining structure contacts at least a portion of the wall of an artery, vein, left atrial appendage, aneurysm, biological conduit, or other blood-containing or biological space. 28. The medical device of any one of claims 1-27, wherein the second catheter can be separated from the balloon at times by pulling the second catheter and the balloon apart. The wall of the first catheter is continuous and the wall of the segment of the second catheter passing through the central void of the balloon is such that the fluid flows from the second lumen of the second catheter. 29. The medical device of any one of claims 1-28, comprising a second segment opening for outflow. The second proximal hub of the second catheter is proximal to the first proximal hub of the first catheter, and a portion of the second catheter is the first catheter of the first catheter. 30. Any one of claims 1-29, passing through one lumen, and wherein the second distal end of the second catheter is distal to the first distal end of the first catheter. A medical device as described in . The one or more second medical devices are metal coils, metal coils, polymer coils, metal and polymer composite coils, coiled polymer wires, coiled metal wires, coiled metal wires, metal and 2. The medical device of claim 1, comprising an elongated body comprising a polymer composite wire coil, a polymer strand, a metal strand, a metal strand, a metal and polymer composite strand, a vascular coil, or combinations thereof. The one or more second medical devices may be an assembly of polymer strands, an assembly of metal and polymer composite wires or strands, an assembly of coiled metal wires, an assembly of coiled metal wires, a coiled polymer strand. Metal and Polymer Composite Coiled Structure Metal Strand Assembly Metal Strand Assembly Metal and Polymer Composite Strand Assembly Metal and Polymer Composite Braided Wire Assembly Braided Polymer Strand Assembly Metal and polymer composite braided strand assemblies, metal mesh assemblies, metal mesh assemblies, metal and polymer composite mesh assemblies, polymer strand woven fabric assemblies, metal and polymer composite strand woven fabric assemblies, or any of these 11. The medical device of Claim 1, further comprising a combination. The one or more second medical devices are metal coils, metal coils, polymer coils, metal and polymer composite coils, coiled polymer wires, coiled metal wires, coiled metal wires, metal and polymer composite wire coils, polymer strands, metal strands, metal strands, metal and polymer composite strands, metal wire assemblies, metal wire assemblies, polymer strand assemblies, metal and polymer composite wire or strand assemblies, Coiled Metal Wire Assembly Coiled Metal Wire Assembly Coiled Polymer Strand Assembly Metal and Polymer Composite Coiled Structure Polymer Strand Assembly Metal Strand Assembly Metal Strand Assembly , Metal and Polymer Composite Strand Assembly, Braided Metal Wire Assembly, Braided Metal Wire Assembly, Metal and Polymer Composite Braided Wire Assembly, Braided Polymer Strand Assembly, Metal and Polymer Composite Braided Strand Assembly, Metal An expandable body including an expansion assembly of a mesh assembly, a metal mesh assembly, a metal and polymer composite mesh assembly, a polymer strand woven fabric assembly, a metal and polymer composite strand woven fabric assembly, or a combination thereof 2. The medical device of claim 1, comprising: The one or more second medical devices comprise a balloon support structure comprising beads, balls, microspheres, bioabsorbable materials, adhesives, glues, solidified polymers, solidified foams, or combinations thereof. Item 1. The medical device according to item 1. The medical device of any one of claims 1-34, wherein the first proximal hub of the first catheter includes a port for injecting fluid into the first lumen. 36. The medical device of any one of claims 1-35, wherein the second proximal hub of the second catheter is configured for injection of fluid into the second lumen. 6. The medical device of claim 5, wherein at least a portion of the proximal neck, the distal neck, or both the proximal neck and the distal neck comprises a layer of radiopaque metal. the detachable assembly comprising:
Coupled to form a first assembly at the first distal end of the first catheter defining a first removable assembly lumen extending from the male proximal end to the male distal end. a tubular male structure comprising: at least one movable arm having a distal tab projecting radially outwardly from the male outer surface;
A tubular female structure coupled to form a second assembly to the proximal neck of said balloon defining a second removable assembly lumen extending from the female proximal end to the female distal end. and in a first configuration, the first assembly may be secured to the second assembly, and in a second configuration, the first assembly is secured to the second assembly by: 2. The medical device of claim 1, further comprising: a freely moving shaft of the second catheter.

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